Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
What this means
Medline has recalled 28 models of surgical convenience kits used in spine and brain surgery. The kits contain neurological sponges with potentially elevated endotoxin levels — bacterial contamination that can cause fever, inflammation, low blood pressure, or other complications during or after surgery.
- Check your facility's inventory against the catalog numbers listed in the FDA notice.
- Do not use affected kits. Contact Medline or the FDA if you have used any recalled kits.
- Review lot numbers with your procurement department to identify affected stock.
- Report any patient symptoms or complications to your medical team and the FDA's MedWatch program.
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-3269-2026Also reported as
More 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
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