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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- Affected units
- 3,684
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.
Part of a larger recall action
This product is one of 18 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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