Custom Procedure Kit — Class II medical device recall Z-3191-2024
Ongoing recall by Merit Medical Systems, Inc., reported 2024-10-02, distributed nationwide. 7F sheath introducers labeled as 7.5F
| Recall number | Z-3191-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc., South Jordan, UT, United States |
| Recall initiated | 2024-08-12 |
| Classified | 2024-09-20 |
| Reported by FDA | 2024-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX |
| Quantity | 24 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00884450457863 |
| Model numbers | K12T-11077 |
Product
Custom Procedure Kit, REF: K12T-11077
Reason for recall
7F sheath introducers labeled as 7.5F
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-3191-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.