Official recall notice
Medline Convenience Kits Recall (Sep 2026)
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
- Recall date
- 2026-09-30
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Product description
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.
Affected products
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