Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T-03201
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | December 04, 2025 |
| Reported | January 28, 2026 |
| Recalling firm | Merit Medical Systems, Inc. |
| Country / region | United States UT |
Hazard
Inflation device handle may detach from the syringe during procedure.
Affected products
- Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674
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