FDA Device recall Z-1578-2023
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
- FDA Device
- Class II
- ongoing
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class II recall of COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units by Merit Medical Systems, citing custom sheath Introducer contains incorrect needle size.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1578-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-21 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Merit Medical Systems |
| Distribution | MN |
Product
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units
Reason
Custom sheath Introducer contains incorrect needle size
Identifiers
| code_info | Lot # H2122096S1; UDI-DI: (00)884450525197 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1578-2023%22
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