medical MODERATE Updated 2026-09-30

Medline Industries, LP recalls Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog N

See all recalls from Medline Industries, LP →

Recalled Product

Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784; 2) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348Q; 3) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348R; 4) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348S; 5) SLUH CRANIOTOMY PACK-LF, Catalog Number: DYNJ0369348T

Share this recall: Facebook X / Twitter WhatsApp Email

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 1) DYNJT8784, UDI-DI: 10198459756368(each), 40198459756369(case), Lot Number: 26EBN238; 2) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25GBC553; 3) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25FBA082; 4) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25EBP462; 5) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25DBU966; 6) DYNJ0369348Q, UDI-DI: 10198459200632(each), 40198459200633(case), Lot Number: 25CBS315; 7) DYNJ0369348R, UDI-DI: 10198459442094(each), 40198459442095(case), Lot Number: 25JBB880; 8) DYNJ0369348R, UDI-DI: 10198459442094(each), 40198459442095(case), Lot Number: 25HBF280; 9) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26CBK932; 10) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26BBT826; 11) DYNJ0369348S, UDI-DI: 10198459656316(each), 40198459656317(case), Lot Number: 26BBT935; 12) DYNJ0369348T, UDI-DI: 10198459733826(each), 40198459733827(case), Lot Number: 26EBG096; 13) DYNJ0369348T, UDI-DI: 10198459733826(each), 40198459733827(case), Lot Number: 26DBM677

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

Looking for a safe alternative?

Search Amazon for Medline Convenience Kits: →
View official government recall