Data Foundry

Medical device recalls 2026

Halyard SAMMC ANGIOGRAPHY kit — Class I medical device recall Z-1978-2026

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-1978-2026
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
Quantity2,392 kits
UPC / GTIN / UDI-DI10809160388495
Lot numbers1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931
Model numbersSAMM066-15

Product

Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.

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-1978-2026. 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.