FDA Device recall Z-1776-2026
COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787
- FDA Device
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787 by Cook, citing products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1776-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-05 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Cook |
| Distribution | n/a |
Product
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
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Identifiers
| code_info | Reference Part Number CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X; Reference P…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1776-2026%22
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