Recall Z-2027-2026— Medline Industries, LP

Name: FDA recall Z-2027-2026
Creator: U.S. Food and Drug Administration
Published: 2026-03-19

Class II · Ongoing

Class II FDA medical device recall by Medline Industries, LP, initiated 2026-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin..

Recalling firm: Medline Industries, LP
Classification: Class II
Status: Ongoing
Initiated: 2026-03-19
Firm location: Northfield, IL, United States

Product description

Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.

Reason for recall

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Data sourced from openFDA. This site is unofficial and independent of the FDA.