MEDLINE INDUSTRIES, LP - Northfield: Device Recall

Recall #Z-3095-2024 · 05/07/2024

Class II: Risk

Recall Details

Recall Number: Z-3095-2024
Classification: Class II
Product Type: Device
Recalling Firm: MEDLINE INDUSTRIES, LP - Northfield
Status: Ongoing
Date Initiated: 05/07/2024
Location: Northfield, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 46 units

Reason for Recall

Potential for an incomplete seal on the packaging tray.

Product Description

Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.

Distribution Pattern

US Nationwide distribution.

Other Recalls by MEDLINE INDUSTRIES, LP - Northfield

Class I: Dangerous 07/25/2025

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

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

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

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

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.

View all recalls by MEDLINE INDUSTRIES, LP - Northfield →

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.