MEDLINE INDUSTRIES, LP - Northfield: Device Recall

Recall Details

Recall Number

Z-0783-2025

Classification

Class II

Product Type

Device

Recalling Firm

MEDLINE INDUSTRIES, LP - Northfield

Status

Ongoing

Date Initiated

11/21/2024

Location

Northfield, IL, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

943 units

Reason for Recall

Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.

Product Description

Medline custom medical procedure kits labeled as: 1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; 2) MVFF/FIBU #54-RF, REF DYNJ21927R; 3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; 4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; 6) DIEP FLAP, REF DYNJ66867A; 7) KIT FREE FLAP MOSES, REF DYNJ905366A; 8) FREE FLAP, REF DYNJ905634B; 9) ROBOTIC THORACIC, REF DYNJ907817; 10) TRANSPHENOIDAL, REF DYNJ908165; 11) METREX, REF DYNJ910072; 12) DIEP FLAP, REF DYNJ910120A.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of UAE, and Canada.

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 →