Data Foundry

Medical device recalls 2026

Halyard CARDIAC CATH PACK kit — Class I medical device recall Z-1970-2026

Ongoing recall by AVID Medical, Inc., reported 2026-05-13, distributed in FL, IL, MO, MS, NC, NE, TX. Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connecti

Recall numberZ-1970-2026
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmAVID Medical, Inc., Toano, VA, United States
Recall initiated2026-03-13
Classified2026-05-01
Reported by FDA2026-05-13
DistributedFL, IL, MO, MS, NC, NE, TX
Quantity222 kits
UPC / GTIN / UDI-DI10809160377314, 10809160424759
Lot numbers1583827, 1609541, 1609725, 1612134, 1612516, 1619132, 1623384, 1627013, 1635459, 1672306
Model numbersEAMC1000-05, WAFB208-02

Product

Halyard CARDIAC CATH PACK kit. Model Number: EAMC1000-05, WAFB208-02.

Reason for recall

Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

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-1970-2026. 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.