Cardinal Health Presource Kits: 1) ENT TRAY — Class II medical device recall Z-2945-2026
Ongoing recall by Cardinal Health 200, LLC, reported 2026-08-19, distributed nationwide. Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in
| Recall number | Z-2945-2026 |
|---|---|
| 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 | 2026-07-14 |
| Classified | 2026-08-13 |
| Reported by FDA | 2026-08-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 87,182 kits |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10195594039493, 10195594069872, 10195594109493, 10195594140809, 10195594164621, 10195594179069, 10195594242633, 10195594257149, 10195594292959, 10195594366759, 10195594440176, 10195594446819, 10195594450007, 10195594454852, 10195594456153, 10195594463182, 10195594500139, 10195594511241, 10195594513542, 10195594553586, 10195594608996, 10195594610326, 10195594638719, 10195594650025, 10195594650032 and 475 more |
| Lot numbers | 100, 1000, 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, 101, 1010, 1011, 1012, 1013, 1014, 1015, 1016, 1017, 1018, 1019, 102, 1020, 1021, 1022, 1023, 1024, 1025, 1026, 1027, 1028, 1029, 103, 1030, 1031, 1032, 1033, 10339, 1034 and 460 more |
| Model numbers | 24-0726A, PE13SPAJA, PE13SPAJB, PE13SPAJC, PE29NSFGP, PE33HNCR1, PE33HNCR2, PE33HNCR3, PE33HNCR4, PE33HNCRA, PE33HNCRB, PE35NSB23, PE35NSBLG, PE44EMKW8 |
Product
Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726A; 2) KIT,SINUS , Catalog Number: PE13SPAJA; 3) KIT,SINUS , Catalog Number: PE13SPAJB; 4) KIT, SINUS , Catalog Number: PE13SPAJC; 5) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE13SPAJC; 6) KIT,NASAL SEPTOPLASTY,F, Catalog Number: PE29NSFGP; 7) KIT, HEAD AND NECK , Catalog Number: PE33HNCR1; 8) KIT, HEAD AND NECK , Catalog Number: PE33HNCR2; 9) KIT, HEAD AND NECK , Catalog Number: PE33HNCR3; 10) KIT, HEAD AND NECK , Catalog Number: PE33HNCR4; 11) KIT, HEAD AND NECK , Catalog Number: PE33HNCRA; 12) KIT, HEAD AND NECK , Catalog Number: PE33HNCRB; 13) KIT, NASAL , Catalog Number: PE35NSB23; 14) KIT, NASAL , Catalog Number: PE35NSBLG; 15) KIT, EENT , Catalog Number: PE44EMKW8;
Reason for recall
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
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-2945-2026. 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.