FDA Device recall Z-1127-2025
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14
- FDA Device
- Class II
- ongoing
- Published 2025-02-19
On 2025-02-19 the FDA classified a Class II recall of Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14 by Cardinal Health 200, citing potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1127-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-08 |
| Published | 2025-02-19 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Cardinal Health Presource Kits: 1) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMM14; 2) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMD9; 3) KIT,NEURO LAMI,MD ANDERSON, Catalog Number:PN76LMMDX;
Reason
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Identifiers
| code_info | 1) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J8241D ; 2) PN76LMM14, UDI-DI:…1) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J8241D ; 2) PN76LMM14, UDI-DI:10888439914467 (each) 50888439914465 (case), Lot Number: J79Z55 ; 3) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220A ; 4) PN76LMMD9, UDI-DI:10888439651416 (each) 50888439651414 (case), Lot Number: J4220D ; 5) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J4953F ; 6) PN76LMMDX, UDI-DI:10888439401318 (each) 50888439401316 (case), Lot Number: J46C13 ; |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1127-2025%22
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