FDA-Device2026-09-02Class IIPROCESSING DEFECT
Medline surgical convenience kits recalled for high endotoxin levels in neurosponges
What this means
Certain lots of Medline medical convenience kits used in craniotomy, spine surgery, ENT, and thyroid procedures contain neurosponges with endotoxin levels above safe limits. Endotoxins are bacterial substances that can trigger immune responses in sterile surgical fields. About 246 kits across multiple states are affected.
- Check your facility inventory against the affected lot numbers listed in the official FDA notice.
- Stop using affected neurosponges and neurosponge strips immediately.
- Return or destroy recalled kits according to your facility's protocol and Medline instructions.
- Contact Medline customer service or your supplier for replacement kits and full details.
The agency's original wording
Hazard
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, IA, ID, IL, IN, MA, MD, MI, MN, MO, MT, NY, OH, TX, WI, WY.
Affected count
246 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2995-2026Also reported as
- FDA-Device2026-09-02Medline surgical convenience kits recalled for elevated endotoxin levels in neurosponges
- FDA-Device2026-09-30Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges
- FDA-Device2026-09-30Medline craniotomy surgical kits recalled for endotoxin contamination risk
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
- 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 convenience kits recalled for sharp brush edges in Healthmark channel brushes
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