Cardinal Health Presource Kits: 1) KIT — Class II medical device recall Z-1126-2025
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-1126-2025 |
|---|---|
| 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 | 10195594017668, 10195594018535, 10195594042929, 10195594057909, 10195594060954, 10195594063061, 10195594067557, 10195594101602, 10195594116903, 10195594118754, 10195594120450, 10195594130510, 10195594142469, 10195594145552, 10195594150792, 10195594163426, 10195594165680, 10195594167332, 10195594169565, 10195594171285, 10195594172978, 10195594198343, 10195594213206, 10195594240776, 10195594252014 and 475 more |
| Lot numbers | 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115, 116, 117, 118, 119, 120, 121, 122, 123, 124, 125, 126, 127, 128, 129, 130, 131, 132, 133, 134, 135, 136, 137, 138, 139 and 460 more |
| Model numbers | PB23DFCM3, PB23DFCM4, PB23DFCM5, PB23DFCM6, PB23DFCM7, PB23DFCMA, PE40HNAJ10, PE40HNAJ11, PE40HNAJ12, PE40HNAJ13, PE40HNAJ14, PE40HNAJ15, PE40HNAJ16, PE40HNAJ17, PE40HNAJ18, PE40HNAJ19, PE40HNAJ20, PE40HNAJU1, PE40HNAJU2, PE40HNAJU3, PE40HNAJU4, PE40HNAJU5, PE40HNAJU6, PE40HNAJU7, PE40HNAJU8 and 38 more |
Product
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5) KIT,DIEP FLAP , Catalog Number:PB23DFCM7; 6) KIT,DIEP FLAP , Catalog Number:PB23DFCMA; 7) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ10; 8) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ11; 9) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ12; 10) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ13; 11) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ14; 12) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ15; 13) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ16; 14) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ17; 15) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ18; 16) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ19; 17) KIT, HEAD AND NECK , Catalog Number:PE40HNAJ20; 18) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU1; 19) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU2; 20) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU3; 21) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU4; 22) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU5; 23) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU6; 24) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU7; 25) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU8; 26) KIT, HEAD AND NECK , Catalog Number:PE40HNAJU9; 27) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUA; 28) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUB; 29) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUC; 30) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUD; 31) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUE; 32) KIT, HEAD AND NECK , Catalog Number:PE40HNAJUF; 33) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU2; 34) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU3; 35) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU4; 36) KIT, HEAD AND NECK , Catalog Number:PG40HNAJU5; 37) KIT, HEAD AND NECK , Catalog Number:PG40HNAJUC; 38) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ10; 39) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ11; 40) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ12; 41) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ13; 42) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ14; 43) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ15; 44) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ16; 45) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ17; 46) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ18; 47) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ19; 48) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ20; 49) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ21; 50) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ22; 51) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ23; 52) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJ24; 53) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU4; 54) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU5; 55) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU6; 56) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU7; 57) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU8; 58) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJU9; 59) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUE; 60) KIT, FREE FLAP HEAD , Catalog Number:PG40HNJUF; 61) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME1; 62) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME2; 63) KIT, WILLIAMS SPINE , Catalog Number:PN23WGME3; 64) KIT, WILLIAMS SPINE , Cat
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-1126-2025. 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.