The Recall Desk
HighFDA (Devices)·Z-0777-2025·Announced 2025-01-08

Medline surgical procedure kits recalled for non-sterile supplies

Medline is recalling custom medical procedure kits containing non-sterile surgical supplies with potential endotoxin contamination. The affected kits were distributed nationwide and internationally.

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 non-sterile surgical supplies distributed for use in critical medical procedures. Although no illnesses or injuries have been reported, the potential for endotoxin contamination in surgical kits poses a significant risk of harm to patients, meeting the criteria for High severity.

Plain-English summary

Medline Industries, LP is recalling custom medical procedure kits because they contain non-sterile Codman Surgical Patties and Surgical Strips that have the potential for endotoxin contamination. The affected kits include five product types: CATH LAB PACK-LF, CRANI, GENDER AFFIRMING SURGERY (two versions), and MAJOR NEURO PACK-LF, totaling 1,236 units.

These kits were distributed nationwide in the United States as well as to the United Arab Emirates and Canada. The non-sterile surgical components pose a risk of endotoxin exposure during surgical procedures, which could cause complications for patients undergoing these critical medical procedures.

Healthcare facilities and medical practitioners who have received these kits should stop using them immediately and contact Medline Industries for instructions on return and replacement. Affected lot numbers are identified in the FDA recall notice.

The recalled product

Product
Medline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF DYNJ0382559M; 2) CRANI, REF DYNJ56001B; 3) GENDER AFFIRMING SURGERY, REF DYNJ66252; 4) GENDER AFFIRMING SURGERY, REF DYNJ66252A; 5) MAJOR NEURO PACK-LF, REF DYNJ0578916X.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical procedure kits
Hazard
  • endotoxin-contamination
  • non-sterile-supplies

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 DYNJ0382559M
  • UDI/DI 10889942063994 (EA) 10889942063995 (CS)
  • Lot Numbers: 19TBC792
  • 2) REF DYNJ56001B
  • UDI/DI 10889942798278 (EA) 40889942798279 (CS)
  • Lot Numbers: 19BDC737
  • 19FDA310
  • 19FDB230
  • 19JDA441
  • 3) REF DYNJ66252
  • UDI/DI 10193489324785 (EA) 40193489324786 (CS)
  • Lot numbers: 20DBK065
  • 20FBN251
  • 20HBL176
  • 20HBM692
  • 21CBP776
  • 4) REF DYNJ66252A
  • UDI/DI 10193489887853 (EA) 40193489887854 (CS)
  • Lot numbers: 21IBN151
  • 21KBO915

Distribution

Distributed nationwide across the United States.

Related recalls

Same category