Class II — Merit Medical Systems, Inc.
| Recalling firm | Merit Medical Systems, Inc. |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 7F sheath introducers labeled as 7.5F |
| Product | Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F) |
| Quantity | 1892 |
| Distribution | Worldwide - US Nationwide distribution in the states of WI, MN, TX, PA, GA, NE, CA, AR, MS, MA, MI, OH, CO, NV, OR, AZ, NC and the country of Mexico. |
| Initiated | 2024-08-12 |
| Classified | 2024-09-20 |
| Recall number | Z-3190-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Merit Medical Systems, Inc. (Z-3190-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95234/
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