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Merit Medical®
Merit Medical Systems, Inc. · Model Initial Release · UDI-DI 00884450108758
PPD
Prescription
0
510(k) clearances
12
Adverse events
4
Recalls
18
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-04 | Merit Medical Systems, Inc. | Inflation device handle may detach from the syringe during procedure. |
| 2025-12-04 | Merit Medical Systems, Inc. | Inflation device handle may detach from the syringe during procedure. |
| 2025-06-05 | Merit Medical Systems, Inc. | High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may resu |
| 2024-06-11 | Merit Medical Systems, Inc. | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.