Z-1776-2026 Class II Ongoing
FDA device recall Z-1776-2026 was initiated by Cook Incorporated on March 5, 2026 and is designated Class II. Reason for recall: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. The recall status is ongoing. Affected quantity: 49 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 15, 2026
- Initiation Date
- March 5, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 units
Product Description
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
Reason for Recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Distribution Pattern
Worldwide distribution.
Code Information
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.