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FDAFDA · Food and drugs·Recall number Z-3267-2026

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

Published September 30, 2026 · Recall initiated: August 10, 2026

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Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the 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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Medline Industries, LP
Distributor
US Nationwide.
Lot
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
Risk classification
Class II
Area (FDA)
device
Country
United States

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Questions about this recall

Was 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 recalled?

Yes. FDA published recall Z-3267-2026 on September 30, 2026. Reported 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.

What should I do if I have this product?

Voluntary: Firm initiated · Letter

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