Recall archive / FDA device enforcement
COBRA-OS, custom Sheath Introducer Kit, 4 French, REF: E01P2, Sterile EO, Single Use, RX Only, 5 Units — FDA record Z-1578-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 21, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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
- Classification
- Class II
- Recalling firm
- Merit Medical Systems, Inc.
- Quantity
- 1186 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1578-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # H2122096S1; UDI-DI: (00)884450525197 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to state of: Minnesota
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 17, 2023
- Recall initiation date
- Mar 21, 2023
- Center classification date
- May 10, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.