The Recall Desk
HighFDA (Devices)·Z-0783-2025·Announced 2025-01-08

Medline Surgical Procedure Kits Recalled for Non-Sterile Components

Medline is recalling 943 custom surgical kits containing non-sterile Codman Surgical Patties and Strips that may be contaminated with endotoxin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II recall of surgical supplies with non-sterile components that have potential for endotoxin contamination. While the hazard represents a genuine risk of harm in surgical procedures, the source text reports no illnesses or injuries, meeting the criterion for High severity as a risk-of-harm product without reported incidents.

Plain-English summary

Medline Industries is recalling 943 custom surgical procedure kits. The kits contain non-sterile Codman Surgical Patties and Surgical Strips, which have potential for endotoxin contamination.

The affected kits include twelve different product lines with various reference numbers and specific lot numbers. These kits were distributed worldwide, including in the United States, United Arab Emirates, and Canada.

Users of these kits should discontinue use immediately and contact Medline Industries for guidance on replacement or proper disposal.

The recalled product

Product
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 DYNJ58648
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • endotoxin-contamination
  • sterility-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) REF DYNJ0991320J
  • UDI/DI 10193489686661 (EA) 40193489686662 (CS)
  • Lot Numbers: 19EKB321
  • 19GKD099
  • 19JKA065
  • 19LKB378
  • 20DKA223
  • 20EKA239
  • 20FKB859
  • 20GKA150
  • 20HKB438
  • 21ALA327
  • 2) REF DYNJ21927R
  • UDI/DI 10195327104733 (EA) 40195327104734 (CS)
  • Lot Numbers: 23JBK732
  • 3) REF DYNJ40406A
  • UDI/DI 10889942215904 (EA) 40889942215905 (CS)
  • Lot Numbers: 23HBD879
  • 4) REF DYNJ51818F
  • UDI/DI 10889942741601 (EA) 40889942741602 (CS)

Distribution

Distributed nationwide across the United States.

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