FDA Device recall Z-3267-2026
Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784
- FDA Device
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of Medline Convenience Kits: 1) MFC CRANIOTOMY PACK, Catalog Number: DYNJT8784 by Medline Industries, citing the kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3267-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-10 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Medline Industries |
| Distribution | US |
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
Reason
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.
Identifiers
| code_info | 1) DYNJT8784, UDI-DI: 10198459756368(each), 40198459756369(case), Lot Number: 26EBN238; 2) DYNJ0369348Q, UDI-DI: 101984…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; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3267-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.