Class II
Medical Device Recall: Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
Medline Industries, LP · March 19, 2026
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.
Distribution
Worldwide distribution.
Quantity Affected
263739 kits
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2027-2026
Status: ongoing
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