FDA Device recall Z-1130-2025
Cardinal Health Presource Kits: 1) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104
- 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,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104 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-1130-2025 |
| 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,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF104; 2) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF105 3) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF106 4) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF107 5) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF108 6) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF109 7) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10V 8) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10W 9) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Y 10) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF10Z 11) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF111 12) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MF112 13) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCP2 14) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP3 15) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCP4 16) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPA 17) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPB 18) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPC 19) KIT,MAXILLOFACIAL,PRESBYTERIAN, Catalog Number:PWV2MFCPD 20) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPE 21) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number:PWV2MFCPF
Reason
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Identifiers
| code_info | 1) PWV2MF104, UDI-DI:10888439676167 (each) 50888439676165 (case), Lot Number: J46C10 ; 2) PWV2MF105, UDI-DI:…1) PWV2MF104, UDI-DI:10888439676167 (each) 50888439676165 (case), Lot Number: J46C10 ; 2) PWV2MF105, UDI-DI:10195594004217 (each) 50195594004215 (case), Lot Number: J8998R ; 3) PWV2MF106, UDI-DI:10195594095994 (each) 50195594095992 (case), Lot Number: 5136000 ; 4) PWV2MF107, UDI-DI:10195594148065 (each) 50195594148063 (case), Lot Number: 5140389 ; 5) PWV2MF108, UDI-DI:10195594228941 (each) 50195594228949 (case), Lot Number: 5140389 ; 6) PWV2MF109, UDI-DI:10195594394875 (each) 50195594394873 (case), Lot Number: J65K18 ; 7) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: HP1027 ; 8) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4220A ; 9) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J43W15 ; 10) PWV2MF10V, UDI-DI:10888439342741 (each) 50888439342749 (case), Lot Number: J4953C ; 11) PWV2MF10V, UDI-DI:108884 |
|---|
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-1130-2025%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.