Cardinal Health Presource Kits: 1) KIT — Class II medical device recall Z-1130-2025
Ongoing recall by Cardinal Health 200, LLC, reported 2025-02-19, distributed nationwide. Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
| Recall number | Z-1130-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2024-11-08 |
| Classified | 2025-02-10 |
| Reported by FDA | 2025-02-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SA |
| Quantity | 973,785 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195594004217, 10195594095994, 10195594148065, 10195594180294, 10195594228941, 10195594394875, 10195594634957, 10195594711177, 10197106143469, 10197106245491, 10197106368718, 10197106425701, 10197106484340, 10197106532461, 10197106548059, 10197106738399, 10197106784167, 10888439342741, 10888439676167, 10888439693645, 10888439967432, 50195594004215, 50195594095992, 50195594148063, 50195594180292 and 17 more |
| Lot numbers | 5136000, 5140389, 5775812, 5858469, 6022146, 6116189, 6251076, 6701855, 6702040, 6788690, 6788692, 7160517, 7160540, 7287574, 7287577, 7331480, 7333448, 7360541, HP1027, J4220A, J43W15, J46C10, J4953C, J6022K, J6372Z, J65K18, J65K19, J7708T, J8241D, J84K10, J84K11, J8998R |
| Model numbers | PWV2MF104, PWV2MF105, PWV2MF106, PWV2MF107, PWV2MF108, PWV2MF109, PWV2MF10V, PWV2MF10W, PWV2MF10Y, PWV2MF10Z, PWV2MF111, PWV2MF112, PWV2MFCP2, PWV2MFCP3, PWV2MFCP4, PWV2MFCPA, PWV2MFCPB, PWV2MFCPC, PWV2MFCPD, PWV2MFCPE, PWV2MFCPF |
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 for recall
Potential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1130-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.