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 | Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier. |
| Product | Waste Management Kit. Catalog Number K10-04381AP |
| Quantity | 30 units |
| Distribution | Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees. |
| Initiated | 2016-09-23 |
| Classified | 2016-11-19 |
| Terminated | 2017-03-27 |
| Recall number | Z-0633-2017 |
| 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-0633-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75367/
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