FDA Device recall Z-1641-2025
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO…
- FDA Device
- Class II
- ongoing
- Published 2025-04-30
On 2025-04-30 the FDA classified a Class II recall of Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO… by Merit Medical Systems, citing update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1641-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-14 |
| Published | 2025-04-30 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Merit Medical Systems |
| Distribution | US |
Product
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Reason
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Identifiers
| code_info | All Lots/ UDI: 00810275014011 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1641-2025%22
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