FDA DevicesClass II
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-19...
Published: April 15, 2026Recall ID: Z-1776-2026Category: devicesCountry: US
Reason for Recall / Hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Product Description & Identification
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Affected Products
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
Additional Source Details
| Field | Value |
|---|---|
| City | Bloomington |
| State | IN |
| Event id | 98495 |
| Address 1 | 750 N Daniels Way |
| Code info | Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X; Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)281203(10)15783003X, Lot Number 15783003X; Reference Part Number CMW-14-300-12G, UDI (01)00827002507913(17)260227(10)15416547, Lot Number 15416547. |
| Postal code | 47404-9120 |
| Report date | 20260415 |
| Product type | Devices |
| Product quantity | 49 units |
| Reason for recall | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260305 |
| Initial firm notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
| Center classification date | 20260406 |
Overview
- Recalling FirmCook Incorporated
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution.