Data Foundry

Medical device recalls 2025

Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK — Class II medical device recall Z-1131-2025

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 numberZ-1131-2025
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCardinal Health 200, LLC, Waukegan, IL, United States
Recall initiated2024-11-08
Classified2025-02-10
Reported by FDA2025-02-19
DistributedNationwide (US)
Countries outside the USCA, SA
Quantity973,785 units
Reason classessterility
UPC / GTIN / UDI-DI10885425517206, 50885425517204
Lot numbers5136008, 5405613, J4219A, J4678M, J53W13, J6277W, J6785Z, J6786D, J7904P, J8491U, J9602P, J96A00, J96N37, PO351726
Model numbersSRIET0979N

Product

Cardinal Health Presource Kits: 1) LARYNGOSCOPY PACK, Catalog Number:SRIET0979N;

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-1131-2025. 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.