FDA Device recall Z-1127-2026
Merit Medical , Custom Manifold Kit REF: K09-13203A
- FDA Device
- Class II
- ongoing
- Published 2026-01-28
On 2026-01-28 the FDA classified a Class II recall of Merit Medical , Custom Manifold Kit REF: K09-13203A by Merit Medical Systems, citing inflation device handle may detach from the syringe during procedure.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1127-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-04 |
| Published | 2026-01-28 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Merit Medical , Custom Manifold Kit REF: K09-13203A
Reason
Inflation device handle may detach from the syringe during procedure.
Identifiers
| code_info | K09-13203A: UDI: 00884450479964 /Lot: H2671718 H2681531 H2758436 H2792533 H2796074 H3046979 H3052442 H3147779 H3246149 H3254530 H3297407 |
|---|
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-1127-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.