The Recall Desk
HighFDA (Devices)·Z-0784-2025·Announced 2025-01-08

Medline Custom Surgical Procedure Kits Recalled for Potential Endotoxin Contamination

Medline Industries is recalling custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential endotoxin contamination. Approximately 1,072 units were distributed in the US, Canada, and UAE.

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 an FDA Class II recall involving potential endotoxin contamination in surgical supplies, classified as a risk-of-harm product. No illnesses or injuries have been reported; the contamination is described as a potential rather than confirmed hazard.

Plain-English summary

Medline Industries, LP is recalling custom medical procedure kits containing non-sterile Codman Surgical Patties and Surgical Strips. These supplies have the potential for endotoxin contamination, which may pose a risk during surgical procedures.

The recalled kits are labeled as: ENDOSCOPIC SKULL BASE (reference numbers DYNJ58648B, DYNJ58648C, DYNJ58648D, DYNJ58648J) and ENT ENDO SINUS WILMINGTON PACK (reference number DYNJ66447). Approximately 1,072 units were distributed to surgical facilities in the United States, Canada, and the United Arab Emirates.

Healthcare facilities that received any of the affected kits should immediately discontinue use and contact Medline Industries for instructions regarding return or disposal of the recalled products.

The recalled product

Product
Medline custom medical procedure kits labeled as: 1) ENDOSCOPIC SKULL BASE, REF DYNJ58648B; 2) ENDOSCOPIC SKULL BASE, REF DYNJ58648C; 3) ENT ENDO SINUS WILMINGTON PACK, REF DYNJ66447; 4) ENDOSCOPIC SKULL BASE, REF DYNJ58648D; 5) ENDOSCOPIC SKULL BASE, REF DYNJ58648J.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • endotoxin
  • non-sterile

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 DYNJ58648B
  • UDI/DI 10193489624182 (EA) 40193489624183 (CS)
  • Lot Numbers: 19BDB193
  • 2) REF DYNJ58648C
  • UDI/DI 10193489688542 (EA) 40193489688543 (CS)
  • Lot Numbers: 19EDD585
  • 19IDA770
  • 20AMA033
  • 20AMC750
  • 20EMB449
  • 3) REF DYNJ66447
  • UDI/DI 10193489367379 (EA) 40193489367370 (CS)
  • Lot Numbers: 20KMC595
  • 21AMB129
  • 4) REF DYNJ58648D
  • UDI/DI 10195327212124 (EA) 40195327212125 (CS)
  • Lot Numbers: 22KMD675
  • 23DMD129
  • 23HMG766
  • 23JMD938

Distribution

Distributed nationwide across the United States.

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