Agency classClass IIOur severity:High FDA (Devices)·Z-0792-2025·Announced 2025-01-08

Medline Medical Procedure Kits Recalled for Non-Sterile Component Contamination

Medline Industries is recalling 2,664 custom medical procedure kits containing non-sterile surgical components with potential endotoxin contamination. The affected kits were distributed in the US, UAE, 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: FDA Class II medical device recall involving non-sterile surgical components with potential for endotoxin contamination. No illnesses or injuries have been reported, meeting the High severity threshold for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Medline Industries, LP is recalling three types of custom medical procedure kits: ENSEMBLE RACHIS-LF (REF DYNJ47568B), UROLOGY ROBOTIC (REF DYNJ55555D), and KIT, SPINE LH (REF DYNJ906448A). A total of 2,664 units have been distributed.

The kits are being recalled because they contain non-sterile Codman Surgical Patties & Surgical Strips that have the potential for endotoxin contamination. The products were distributed in the United States, United Arab Emirates, and Canada.

Customers who have received these kits should cease use and contact Medline Industries for information on returns or replacement.

The recalled product

Product: Medline custom medical procedure kits labeled as: 1) ENSEMBLE RACHIS-LF, REF DYNJ47568B; 2) UROLOGY ROBOTIC, REF DYNJ55555D; 3) KIT,SPINE LH, REF DYNJ906448A.
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Category: Medical Device — Surgical Kits / Procedure Kits
Hazard: non-sterile
endotoxin-contamination
Affected units: 2,664

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 DYNJ47568B
UDI/DI 10193489846058 (EA) 40193489846059 (CS)
Lot Numbers: 21EBP877
21EBP891
21GBW057
21GBW059
21KBG927
21WBA306
22ABO417
22EBE351
22FBX502
22FBY332
22IBJ001
22LBA177
23ABD998
23BBE825
23CBI861
23EBO916
23FBQ324
23GBN118

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.

See all 18 products in this recall →

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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