Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
What this means
Medline Industries is recalling seven surgical convenience kits used in neurosurgery procedures. The neurological sponges in these kits may contain higher-than-expected endotoxin levels (bacterial toxins), which could cause adverse reactions during or after surgery.
- Check if your facility received any of the seven recalled kit models listed in the recall notice.
- Contact Medline Industries for instructions on returning or replacing affected kits.
- Review affected patient records and consult with medical staff if any patients received treatment with these kits.
The agency's original wording
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neurovascular adverse events, febrile response, and/or local transient inflammation, hypotension, or nausea.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3268-2026More Medline recalls
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline Convenience Kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline sinus convenience kits recalled for sharp brush edges risking cut injury
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline convenience kits recalled for sharp brush edges in Healthmark channel brushes
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