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 | Terminated |
| Reason | labeling error: Due to a manufacturing issue, product package was incorrectly labeled with the incorrect sheath size and the incorrect sheath assembly was included in the product packaging. The use of the incorrect kit components may result in vasoconstriction, moderate hemorrhage, and/or embolism. |
| Product | Custom Sheath Introducer Kit REF K21-00031 - Product Usage: intended use is to provide access and facilitate the percutaneous introduction of various devices into vein. |
| Quantity | 15 kits |
| Distribution | US Nationwide distribution in the state of MI. |
| Initiated | 2019-09-12 |
| Classified | 2020-05-11 |
| Terminated | 2022-05-27 |
| Recall number | Z-1956-2020 |
| 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-1956-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85342/
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