The Recall Desk
HighFDA (Devices)·Z-0787-2025·Announced 2025-01-08

Medline Surgical Procedure Kits Recalled Due to Sterility Concerns

Medline is recalling custom surgical procedure kits that contain non-sterile surgical supplies with potential for endotoxin contamination. The kits were distributed worldwide, including the United States, United Arab Emirates, 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 a Class II recall involving high-risk contamination (endotoxins in surgical supplies used in sterile procedures). However, no illnesses or injuries have been reported, and the hazard is described as potential contamination rather than confirmed contamination causing harm.

Plain-English summary

Medline Industries is recalling custom neurosurgical procedure kits due to concerns about sterility and potential endotoxin contamination. The recalled products are NEURO BASIN PACK-LF (REF DYNJ39461J) and NEURO BASIN KIT (REF DYNJ80200B). These kits contain non-sterile Codman Surgical Patties and Surgical Strips.

The recall affects approximately 3,684 units distributed worldwide, including the United States, United Arab Emirates, and Canada. Specific lot numbers are identified for both kit types.

Endotoxins are bacterial toxins that can cause serious infection if introduced into the body during surgical procedures. Because these supplies are intended for use in sterile surgical environments, potential endotoxin contamination poses a health risk to patients undergoing procedures with these kits.

Healthcare facilities and consumers with these kits should stop using them immediately. Contact Medline Industries for information about returns or proper disposal. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Medline custom medical procedure kits labeled as: 1) NEURO BASIN PACK-LF, REF DYNJ39461J; 2) NEURO BASIN KIT, REF DYNJ80200B.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Procedure Kits
Hazard
  • endotoxin
  • infection-risk

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 DYNJ39461J
  • UDI/DI 10195327112721 (EA) 40195327112722 (CS)
  • Lot Numbers: 22BBZ954
  • 22FBB472
  • 22GBS127
  • 22HBJ021
  • 22IBN757
  • 22LBN387
  • 22LBP618
  • 23BBL804
  • 23FBL965
  • 23HBG346
  • 23IBV491
  • 23JBW568
  • 24ABJ924
  • 24CBG585
  • 24DBM211
  • 24FBN899
  • 24FBQ913
  • 24HBL252

Distribution

Distributed nationwide across the United States.

Related recalls

Same category