Recall archive / FDA device enforcement
Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 — FDA record Z-0499-2025
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 Oct 14, 2024. 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
- Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
- Reason
- Devices from the affected device lots have labels that state the incorrect expiration dates.
- Classification
- Class II
- Recalling firm
- Cook Incorporated
- Quantity
- 10 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0499-2025
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 | UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International Distribution to: Korea only
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Nov 27, 2024
- Recall initiation date
- Oct 14, 2024
- Center classification date
- Nov 21, 2024
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.