Data Foundry

Medical device recalls 2026

Cardinal Health Presource Kits: 1) BASIC PACK — Class II medical device recall Z-2949-2026

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 numberZ-2949-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCardinal Health 200, LLC, Waukegan, IL, United States
Recall initiated2026-07-14
Classified2026-08-13
Reported by FDA2026-08-19
DistributedNationwide (US)
Countries outside the USCA
Quantity616 kits
Reason classessterility
UPC / GTIN / UDI-DI10197106817186, 10198956354616, 10888439842746, 10888439874891, 50197106817184, 50198956354614, 50888439842744, 50888439874899
Lot numbers10392, 11020, 11020-1, 12206, 14039, 14813, 15192, 15192-1, 15463-1, 15463-5, 15463-6, 15463-7, 6033, 8160, 8160-2, 9243-1, 9243-2
Model numbersSBA73BPGCA, SNE11SPHKC, SNE11SPHKD, SNE12BS01B

Product

Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Number: SBA73BPGCA; 2) SPINE PACK , Catalog Number: SNE11SPHKC; 3) SPINE PACK , Catalog Number: SNE11SPHKD; 4) CRANIOTOMY PACK , Catalog Number: SNE12BS01B

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-2949-2026. 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.