- Recalling firm
- AVID Medical, Inc.
- 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.
- Affected products (lot / model / serial)
- 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).
- Units affected
- 6,956 kits
- Distribution pattern
- US distribution to FL, IL, MO, MS, NC, NE, TX.
- Firm location
- Toano, VA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-1972-2026
- Recall initiated
- March 13, 2026
- FDA classification date
- May 1, 2026
- FDA report date
- May 13, 2026
- FDA event ID
- 98686
- Last updated on HTM Vibe
- July 24, 2026