FDA Device recall Z-1977-2026
Halyard PERC TRAY kit
- FDA Device
- Class I
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class I recall of Halyard PERC TRAY kit by Avid Medical, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1977-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-03-13 |
| Published | 2026-05-13 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Avid Medical |
| Distribution | FL, IL, MO, MS, NC, NE, TX |
Product
Halyard PERC TRAY kit. Model Numbers: SLPC34-01, SLPC34-02.
Reason
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.
Identifiers
| code_info | 1. Model Number: SLPC34-01. UDI-DI (Kit Lot Numbers): 10809160450963 (1640169, 1641409, 1641410, 1641411, 1641412, 1641…1. Model Number: SLPC34-01. UDI-DI (Kit Lot Numbers): 10809160450963 (1640169, 1641409, 1641410, 1641411, 1641412, 1641413, 1641414, 1641415, 1645684); 10809160459904 (1649576, 1660882, 1660883, 1660884, 1663896, 1665768). 2. Model Number: SLPC34-02. UDI-DI (Kit Lot Numbers): DHR 108916049515 NAV 10809160511213 (1668809, 1668810, 1668812, 1668813, 1668814, 1668815, 1668816). |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1977-2026%22
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