Medline Convenience Kits recalled for elevated endotoxin levels in sponges
What this means
Medline's surgical convenience kits contain neurological sponges with unexpectedly high endotoxin levels—a bacterial byproduct that can trigger serious reactions. The affected kits are used in sinus, nasal, and ENT procedures. Elevated endotoxin exposure may cause fever, inflammation, low blood pressure, or other reactions that need medical care.
- Check if your facility has any of the five recalled Medline kit types and their lot numbers listed in the FDA notice.
- Do not use affected kits; quarantine or return them to Medline.
- Monitor patients treated with these kits for fever, local swelling, or other unusual symptoms and seek care if they occur.
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-3265-2026More Medline recalls
- FDA-Device2026-09-30Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
- FDA-Device2026-09-30Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological 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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