FDA DeviceClass IINotable

FDA Recall: Medline Neuro Sponges, various dimensions, labeled as: 1. Neuro Sponges, Eponges neuro, Neuroes

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

4225160 units

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