FDA DeviceClass IINotable

FDA Recall: Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPINE PACK-LF

Date: 2026-05-06
Brand: Medline Industries, LP
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

104 kits

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