The Recall Desk
HighFDA (Devices)·Z-0786-2025·Announced 2025-01-08

Medline Custom Surgical Kits Recalled for Non-Sterile Components with Endotoxin Risk

Medline Industries is recalling 3,903 custom medical procedure kits due to non-sterile Codman Surgical Patties and Strips with potential for endotoxin contamination. The recall affects products distributed in the US, UAE, and Canada.

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 with no reported illnesses or hospitalizations. However, the potential for endotoxin contamination in surgical procedure kits represents a significant risk of harm, justifying a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling 3,903 units of custom medical procedure kits due to a contamination risk. The kits contain non-sterile Codman Surgical Patties and Surgical Strips with potential for endotoxin contamination.

The recalled products are used for various surgical procedures including maxillofacial, craniotomy, and other specialties. Affected kits include 13 models with reference numbers DYNJ0660040R, DYNJ42833A, DYNJ42833B, DYNJ50692C, DYNJ54736B, DYNJ82735, DYNJ903144C, DYNJ905365A, DYNJ906474, DYNJ906474A, DYNJ907802, DYNJ907863, and DYNJ908264. The kits have been distributed worldwide, including in the US, United Arab Emirates, and Canada.

Healthcare facilities and surgical centers that received these kits should immediately stop using them and contact Medline Industries for return or replacement instructions.

The recalled product

Product
Medline custom medical procedure kits labeled as: 1) MEM MAXILLOFACIAL PACK-LF, REF DYNJ0660040R; 2) FREE FLAP PACK-LF, REF DYNJ42833A; 3) FREE FLAP PACK-LF, REF DYNJ42833B; 4) TYMPANOPLASTY PACK, REF DYNJ50692C; 5) MAJOR CRANIOTOMY SAFETY, REF DYNJ54736B; 6) FREE FLAP CU
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure 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 DYNJ0660040R
  • UDI/DI 10889942220083 (EA) 40889942220084 (CS)
  • Lot Numbers: 19BKB772
  • 19DKB804
  • 19FKB661
  • 19GKD118
  • 19IKA148
  • 19KKB086
  • 20AKB057
  • 20BKB114
  • 20FKB215
  • 20JKA546
  • 20LMA968
  • 20LMF795
  • 21DMA309
  • 21DMF310
  • 21FMA264
  • 21GMB043
  • 21HMD757
  • 21JMC608

Distribution

Distributed nationwide across the United States.

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