FDA-Device2026-09-02Class IIPROCESSING DEFECT

Medline medical convenience kits recalled for elevated endotoxin in neurosponges

OTHERNationwide distributionMedical devices

What this means

Specific lots of Medline medical convenience kits used in sinus, ENT, and head-and-neck procedures contain Pilling Wecksorb Neurosponges and Neurosponge Strips with elevated endotoxin levels that exceed safety specifications. Endotoxin is a bacterial substance that can trigger immune reactions if it comes into contact with sensitive tissues during surgery.

Check your facility's inventory for the affected kit SKUs and lot numbers listed in the FDA notice.
Stop using affected kits immediately and quarantine them.
Contact Medline for return or replacement instructions if you have affected kits.

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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

2262 kits

Manufactured in

3 Lakes Dr, N/A, Northfield, IL, United States

Products

Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU DYNJ58928A; 6) HEAD & NECK PACK, Medline Kit SKU DYNJ83296; 7) TRANSPHENOIDAL PACK, Medline Kit SKU DYNJ89006; 8) SINUS, Medline Kit SKU DYNJ900537D; 9) SINUS, Medline Kit SKU DYNJ900537F; 10) ENT HEAD & NECK, Medline Kit SKU DYNJ903679F; 11) ENT HEAD & NECK, Medline Kit SKU DYNJ903679G; 12) ENT HEAD & NECK, Medline Kit SKU DYNJ903679I; 13) ENT HEAD & NECK, Medline Kit SKU DYNJ903679J; 14) ENT HEAD & NECK, Medline Kit SKU DYNJ903679K.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2994-2026

More Medline recalls

FDA-Device2026-09-30
Medline neurological surgical kits recalled for elevated endotoxin levels in sponges
FDA-Device2026-09-30
Medline Convenience Kits Major Pack recalled for elevated endotoxin levels in neurological sponges
FDA-Device2026-09-30
Medline Convenience Kits recalled for elevated endotoxin levels in sponges
FDA-Device2026-09-30
Medline sinus convenience kits recalled for sharp brush edges risking cut injury
FDA-Device2026-09-30
Medline surgical convenience kits recalled for elevated endotoxin levels in neurological sponges

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