COBRA-OS — Class II medical device recall Z-1578-2023
Ongoing recall by Merit Medical Systems, Inc., reported 2023-05-17, distributed in MN. Custom sheath Introducer contains incorrect needle size
| Recall number | Z-1578-2023 |
|---|---|
| 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 | 2023-03-21 |
| Classified | 2023-05-10 |
| Reported by FDA | 2023-05-17 |
| Distributed | MN |
| Quantity | 1,186 units |
| UPC / GTIN / UDI-DI | 00884450525197 |
| Lot numbers | H2122096S1 |
| Model numbers | E01P2 |
Product
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Reason for recall
Custom sheath Introducer contains incorrect needle size
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-1578-2023. 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.