The Recall Desk
HighFDA (Devices)·Z-0778-2025·Announced 2025-01-08

Medline Surgical Procedure Kits Recalled for Endotoxin Contamination Risk

Medline Industries is recalling 2344 custom surgical kits with non-sterile components that may contain endotoxins. The kits were 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 device recall involving non-sterile surgical components with potential endotoxin contamination in critical-use medical devices. No illnesses or injuries are reported in the source, making this a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling 2344 units of custom surgical procedure kits containing non-sterile Codman Surgical Patties and Surgical Strips that have the potential for endotoxin contamination. The recall includes seven different kit configurations, each identified by specific reference numbers and lot codes.

The affected kits were distributed nationwide in the United States and internationally to the United Arab Emirates and Canada. Detailed information about the affected kit types, reference numbers, and lot codes is available from the FDA recall notice.

The recalled product

Product
Medline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M; 2) NEURO PACK, REFDYNJ41516M; 3) RFD- AAA PACK, REFDYNJ54242B; 4) OPEN HEART A&B, REFDYNJ901203C; 5) OPEN HEART A&B, REFDYNJ901203D; 6) ACDF-LF, REFDYNJ906681B; 7) ACDF-LF, REFDY
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • endotoxin-contamination
  • sterility-defect

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 CDS840451M
  • UDI/DI 10195327417574 (EA) 40195327417575 (CS)
  • Lot Numbers: 24BLA736
  • 2) REF DYNJ41516M
  • UDI/DI 10193489202564 (EA) 40193489202565 (CS)
  • Lot Numbers: 19JKB417
  • 19LKA454
  • 20AKB109
  • 20DKB147
  • 20FKB171
  • 3) REF DYNJ54242B
  • UDI/DI 10195327167097 (EA) 40195327167098 (CS)
  • Lot Numbers: 23GBO400
  • 4) REF DYNJ901203C
  • UDI/DI 10889942572526 (EA) 40889942572527 (CS)
  • Lot numbers: 19BKA270
  • 19CKC053
  • 19EKD526
  • 19FKC478
  • 19HKA796

Distribution

Distributed nationwide across the United States.

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