This is part of a larger recall. The most authoritative record is FDA-Device / Z-2995-2026.

FDA-Device2026-09-02Class IIPROCESSING DEFECT

Medline surgical convenience kits recalled for elevated endotoxin levels in neurosponges

OTHERNationwide distributionMedical devices

What this means

Specific lots of Medline medical convenience kits used in spine and cranial surgery contain Pilling Wecksorb Neurosponges with endotoxin levels above safe specifications. Endotoxin is a bacterial substance that can trigger an immune response if it contacts open tissues during surgery. The affected kits were distributed nationwide to healthcare facilities.

  • Check your facility's inventory against the lot numbers listed in the FDA recall notice
  • Do not use affected kits for surgical procedures
  • Contact Medline Industries for replacement kits or a refund
  • Notify your surgical team and infection prevention staff of this recall
Get recalls like this in a free plain-English brief every Sunday.Get alerts ↓
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
974 kits
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit SKU DYNJT6548; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ44504G; 3) NEURO SPINE PACK, Medline Kit SKU DYNJ45419F; 4) CRANIOTOMY PACK, Medline Kit SKU DYNJ46024F; 5) SPINE PACK, Medline Kit SKU DYNJ54479C; 6) CRANIOTOMY PACK, Medline Kit SKU DYNJ58006B; 7) ORTHO-LAMINECTOMY PACK, Medline Kit SKU DYNJ58014A; 8) SPINE PACK, Medline Kit SKU DYNJ83585; 9) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056; 10) CRANI MT CARMEL, Medline Kit SKU DYNJ900467I; 11) GP-NEURO SPINE PACK-LF, Medline Kit SKU PHS396933009C.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2997-2026

More Medline recalls

Want us to check the next one for you?

We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Free · One email a week · Unsubscribe anytime
By signing up you agree to our Terms and Privacy Policy.