FDA Device recall Z-1973-2026
Halyard CATH LAB kit
- FDA Device
- Class I
- ongoing
- Published 2026-05-13
On 2026-05-13 the FDA classified a Class I recall of Halyard CATH LAB 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-1973-2026 |
| 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 CATH LAB kit. Model Number: SACL75AM.
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 | Model Number: SACL75AM. UDI-DI (Kit Lot Numbers): 10809160413586 (1599684, 1601393). |
|---|
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-1973-2026%22
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