Merit Medical — Class II medical device recall Z-1641-2025
Ongoing recall by Merit Medical Systems, Inc., reported 2025-04-30, distributed nationwide. Update to IFU to provide additional information related to risk with device over-rotation and multiple deploym
| Recall number | Z-1641-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2025-03-14 |
| Classified | 2025-04-21 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BR, EG, ES, IL, SA, TH, TR |
| Quantity | 7,453 units |
| UPC / GTIN / UDI-DI | 00810275014011 |
| Model numbers | R2275 |
Product
Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO,RxOnly
Reason for recall
Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1641-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.