FDA DevicesClass I
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Published: May 13, 2026Recall ID: Z-1978-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Halyard SAMMC ANGIOGRAPHY kit. Model Numbers: SAMM066-15.
Additional Source Details
| Field | Value |
|---|---|
| City | Toano |
| State | VA |
| Event id | 98686 |
| Address 1 | 9000 Westmont Dr |
| Code info | Model Number: SAMM066-15. UDI-DI (Kit Lot Numbers): 10809160388495 (1561685, 1575926, 1583048, 1584017, 1589652, 1595715, 1599634, 1605749, 1611810, 1621476, 1637222, 1637224, 1637225, 1643118, 1645143, 1645637, 1663929, 1663930, 1663931, 1663932). |
| Postal code | 23168-9351 |
| Report date | 20260513 |
| Product type | Devices |
| Product quantity | 2,392 kits |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260313 |
| Initial firm notification | |
| Center classification date | 20260501 |
Overview
- Recalling FirmAVID Medical, Inc.
- StatusOngoing
- Risk LevelClass I
- DistributionUS distribution to FL, IL, MO, MS, NC, NE, TX.