Cardinal Health Presource Kits: 1) KIT — Class II medical device recall Z-0917-2025
Ongoing recall by Cardinal Health 200, LLC, reported 2025-01-22, distributed nationwide. Potential endotoxin contamination in non-sterile surgical strips and patties in Presource kits.
| Recall number | Z-0917-2025 |
|---|---|
| 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 | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, SA |
| Quantity | 512,786 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195594014018, 10195594343477, 10195594914998, 10197106141540, 10197106337004, 10197106340523, 10197106344972, 10197106366837, 10197106431429, 10197106497425, 10197106566107, 10197106644010, 10197106741597, 10888439038620, 10888439551716, 10888439654813, 10888439744729, 10888439828900, 10888439980271, 10888439993639, 50195594014016, 50195594343475, 50195594914996, 50197106141548, 50197106337002 and 15 more |
| Lot numbers | 2300125464, 5135984, 5135997, 5140345, 5140348, 5405626, 5478802, 5533333, 5533334, 5664098, 5664099, 5664103, 5747232, 5891305, 5891307, 5891308, 5891313, 6022130, 6022133, 6025791, 6264567, 6560945, 6563992, 6596396, 6702009, 6702010, 6806114, 6806115, 6914944, 6928758, 6928759, 6928764, 6928766, 6928770, 6928772, 7163103, 7280105, 7280107, 7280108, 7280109 and 30 more |
| Model numbers | PWHFHNAMH1, PWHFHNAMH2, PWHFHNAMH3, PWHFHNAMH4, PWHFHNAMH5, PWHFHNAMH6, SEN55ENSH2, SEN55ENSHA, SEN55ENSHB, SEY51EYKIK, SEYOCPEHH1, SEYOCPEHH2 |
Product
Cardinal Health Presource Kits: 1) KIT, H N FREE FLAP, Catalog Number: PEHFHNAMHJ; 2) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH1; 3) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH2; 4) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH3; 5) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMH4; 6) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH5; 7) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMH6; 8) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHA; 9) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHB; 10) KIT,H N FREE FLAP , Catalog Number: PWHFHNAMHC; 11) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHD; 12) KIT, H N FREE FLAP , Catalog Number: PWHFHNAMHE; 13) ENT PACK , Catalog Number: SEN55ENSH2; 14) ENT PACK , Catalog Number: SEN55ENSHA; 15) ENT PACK , Catalog Number: SEN55ENSHB; 16) EYE PACK , Catalog Number: SEY51EYKIK; 17) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH1; 18) PLASTIC EYE PACK , Catalog Number: SEYOCPEHH2; 19) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHB; 20) PLASTIC EYE PACK , Catalog Number: SEYOCPEHHC;;
Reason for recall
Potential 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-0917-2025. 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.