FDAClass I · Medical device · Recalled May 13, 2026
Halyard CARDIAC CATH TRAY SHANDS JAX kit recall — AVID Medical, Inc.
Hazard: 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.
Class I: most serious — reasonable probability of serious health consequences or death.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- Z-1972-2026
- Brand
- AVID Medical
- Classification
- Class I
- Units affected
- 6,956 kits
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Affected products
Companies & origin
- Recalling firm location
- Toano, VA, United States
- Firm address
- 9000 Westmont Dr, 23168-9351
Identifying details (verbatim from the notice)
- Product codes / lots
- 1. Model Number: SHND401-04. UDI-DI (Kit Lot Numbers): 10809160395615 (1577749, 1577750, 1590780, 1590782, 1590783, 1590784, 1590785, 1590833, 1591141, 1591142, 1597561, 1600738, 1613343, 1622356, 1631890, 1643855, 1643856, 1643860, 1644853, 1645163, 1647458, 1647459, 1647460, 1650983, 1652365, 1652366). 2. Model Number: SHND401-05. UDI-DI (Kit Lot Numbers): 10809160491294 (1652367, 1668844, 1668845, 1668846, 1669188, 1669189, 1669504, 1669506, 1669507, 1671312, 1671313, 1671314, 1671315, 1671316).
- Distribution
- US distribution to FL, IL, MO, MS, NC, NE, TX.
- Firm notified the public via
- E-Mail
- FDA event ID
- 98686
- Recall initiated
- March 13, 2026
- FDA classified
- May 1, 2026
- FDA report date
- May 13, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.
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