MEDLINE INDUSTRIES, LP - Northfield

299 FDA enforcement actions

299 Total Recalls

15 Class I

284 Class II

0 Class III

Firm Details

Product Types: device, drug
States: IL

All Recalls

Class I: Dangerous 07/25/2025 device

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
Class I: Dangerous 07/25/2025 device

Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Flexicare BritePro Solo Fiber Optic Laryngoscope Handles due to the failure of the light to illuminate as intended.
Class II: Risk 07/23/2025 device

Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product information insert sheets. If a mislabeled tray is used, patient risk ranges from minor injury to injury that requires medical intervention, such as infection or local/systemic allergic reaction (anaphylaxis).
Class I: Dangerous 07/14/2025 device

Specific lots of reprocessed electrophysiology catheters may contain small residual particulates.
Class II: Risk 07/08/2025 device

Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.
Class II: Risk 07/07/2025 drug

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II: Risk 07/07/2025 drug

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II: Risk 07/07/2025 drug

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II: Risk 07/07/2025 drug

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II: Risk 07/07/2025 drug

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II: Risk 07/07/2025 drug

Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II: Risk 06/16/2025 device

SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due to a manufacturing issue which affects the seal between the foil lid and plastic container of the Swab Cap. The issue may result in a reduced level of disinfection of the luer access valve, potentially resulting in patient infection/sepsis.
Class II: Risk 06/12/2025 device

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Class II: Risk 06/12/2025 device

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Class II: Risk 06/12/2025 device

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Class II: Risk 06/12/2025 device

Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
Class II: Risk 05/23/2025 device

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Class II: Risk 05/23/2025 device

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Class II: Risk 05/23/2025 device

Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN which was identified that during insertion of the Catheter, the needle is slow to retract or fails to retract.
Class II: Risk 05/15/2025 device

There is a possible packaging defect impacting the outer Tyvec pouch that protects the sterile product.
Class I: Dangerous 04/22/2025 device

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Class I: Dangerous 04/22/2025 device

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Class I: Dangerous 04/22/2025 device

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Class II: Risk 04/09/2025 device

Three is the potential for the retractors to puncture through the sterile packaging.
Class II: Risk 04/09/2025 device

Three is the potential for the retractors to puncture through the sterile packaging.
Class II: Risk 03/24/2025 device

A single lot of the ImmunoCard STAT! Crypto/Giardia Test Kit was inadvertently stored in Medline warehouses at temperatures outside of the labeled storage requirements.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/19/2025 device

It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Class II: Risk 03/05/2025 device

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Class II: Risk 03/05/2025 device

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Class II: Risk 03/05/2025 device

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Class II: Risk 03/05/2025 device

Medline ReNewal has identified that the drip chambers of affected devices may disconnect from the saline line tubing when under tension.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class II: Risk 03/03/2025 device

There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Class I: Dangerous 02/24/2025 device

Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.
Class I: Dangerous 02/21/2025 device

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
Class I: Dangerous 02/21/2025 device

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
Class I: Dangerous 02/21/2025 device

Medline medical procedure kits, containing Medtronic Aortic Root Cannula
Class I: Dangerous 02/21/2025 device

Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
Class II: Risk 02/19/2025 device

There is a potential for the sterility of the device to be compromised.
Class II: Risk 02/19/2025 device

There is a potential for the sterility of the device to be compromised.
Class II: Risk 02/17/2025 drug

Subpotent Drug
Class II: Risk 02/17/2025 drug

Subpotent Drug
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/13/2025 device

Potential breach in pouch packaging which could lead to loss of sterility.
Class II: Risk 02/12/2025 device

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Class II: Risk 02/12/2025 device

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Class II: Risk 02/12/2025 device

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Class II: Risk 02/12/2025 device

The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/11/2025 device

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 02/06/2025 device

Devices may have higher than expected amounts of bacterial endotoxin.
Class II: Risk 01/09/2025 device

Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Class II: Risk 01/09/2025 device

Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to a shorter duration that a skin barrier can effectively adhere to and protect the skin before it needs to be replaced.
Class II: Risk 01/03/2025 device

Medline is recalling medical convenience kits which were assembled with specific Coloplast Foley catheters and Prostatic catheters which were subsequently recalled due to a potential sterility issue detected during testing.
Class I: Dangerous 12/31/2024 device

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Class I: Dangerous 12/31/2024 device

The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub.
Class II: Risk 12/23/2024 device

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Class II: Risk 12/23/2024 device

Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits and distributed.
Class I: Dangerous 12/16/2024 device

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Class I: Dangerous 12/16/2024 device

Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/21/2024 device

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
Class II: Risk 11/18/2024 device

Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Class II: Risk 11/18/2024 device

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Class II: Risk 11/18/2024 device

Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Class II: Risk 11/18/2024 device

Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Class II: Risk 11/18/2024 device

Complaint defects have been noted regarding the adhesive elements of the device and the frame of the holder putting additional pressure on the patient's cheekbones and upper lip which may cause dermal injury depending on the device positioning.
Class II: Risk 11/18/2024 device

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Class II: Risk 11/18/2024 device

Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.
Class II: Risk 11/12/2024 device

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Class II: Risk 11/12/2024 device

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Class II: Risk 11/12/2024 device

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Class II: Risk 11/12/2024 device

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Class II: Risk 11/12/2024 device

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Class II: Risk 11/12/2024 device

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Class II: Risk 11/12/2024 device

Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 11/06/2024 device

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods
Class II: Risk 10/25/2024 device

Identified lots of Olympus product may be missing sterile and manufacturing lot numbers and expiration dates on the sterile packaging. The information can be found on the outer box or zipper bag label. Medline is recalling its kits which utilize affected product as a component.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/23/2024 device

Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Long-term consequences may include unnecessary treatment and/or prolonged hospitalization.
Class II: Risk 10/21/2024 device

Tip protector may fall off within the packaging, resulting in compromised sterile barrier system and loss of sterility.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/16/2024 device

The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position.
Class II: Risk 10/15/2024 device

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Class II: Risk 10/15/2024 device

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Class II: Risk 10/15/2024 device

Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/09/2024 device

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Class II: Risk 10/04/2024 device

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Class II: Risk 10/04/2024 device

Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal gap.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

XXX
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/04/2024 device

It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Class II: Risk 09/03/2024 device

Product has been identified as having holes in the packaging.
Class II: Risk 08/30/2024 device

It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Class II: Risk 08/30/2024 device

It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Class II: Risk 08/30/2024 device

It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making the unit warm to the touch.
Class II: Risk 08/28/2024 device

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II: Risk 08/28/2024 device

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II: Risk 08/28/2024 device

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II: Risk 08/28/2024 device

CONMED Corporation (vendor) initiated a recall for select lot numbers of the Unimax Detachable Endo Pocket. The Detachable Endo Pocket is indicated for use as a receptacle for the collection and extraction of tissues, organs, and calculi during general and laparoscopic procedures. The tube inside the pouch, which detaches during the removal process, may stretch out from the pouch opening if it is not precisely fixed during the production process. Medline has identified that this product is utilized as a component within the Medline-branded convenience kits.
Class II: Risk 08/28/2024 device

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II: Risk 08/28/2024 device

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II: Risk 08/28/2024 device

Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000.
Class II: Risk 06/27/2024 device

XXX
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/27/2024 device

Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction during intermittent suction use.
Class II: Risk 06/18/2024 device

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Class II: Risk 06/18/2024 device

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Class II: Risk 06/18/2024 device

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Class II: Risk 06/18/2024 device

A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Class II: Risk 05/07/2024 device

Potential for an incomplete seal on the packaging tray.
Class II: Risk 05/07/2024 device

Potential for an incomplete seal on the packaging tray.
Class II: Risk 05/07/2024 device

Potential for an incomplete seal on the packaging tray.
Class II: Risk 05/07/2024 device

Potential for an incomplete seal on the packaging tray.
Class II: Risk 04/30/2024 device

There is the potential of the tip protector to fall off 4.5" sterile, curved, Iris Scissors
Class II: Risk 04/22/2024 device

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Class II: Risk 04/22/2024 device

It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Class II: Risk 04/17/2024 device

These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
Class II: Risk 01/10/2024 drug

Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.
Class II: Risk 10/04/2023 drug

CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.