Data Foundry

Medical device recalls 2026

Halyard CARDIAC CATH TRAY SHANDS JAX kit — Class I medical device recall Z-1972-2026

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-1972-2026
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
Quantity6,956 kits
UPC / GTIN / UDI-DI10809160395615, 10809160491294
Lot numbers1577750, 1590780, 1590782, 1590783, 1590784, 1590785, 1590833, 1591141, 1591142, 1597561, 1600738, 1613343, 1622356, 1631890, 1643855, 1643856, 1643860, 1644853, 1645163, 1647458, 1647459, 1647460, 1650983, 1652365, 1668844, 1668845, 1668846, 1669188, 1669189, 1669504, 1669506, 1669507, 1671312, 1671313, 1671314, 1671315
Model numbersSHND401-04, SHND401-05

Product

Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.

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-1972-2026. 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.