⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Cook Incorporated: COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300

Medical DevicesSource: FDA (device) · Date: 2026-04-15

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Cook Incorporated
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 / hazard
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Classification
Class II
Status
Ongoing
Distribution / sold at
Worldwide distribution.
Recall initiated
2026-03-05
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.
Product quantity
49 units
Voluntary mandated
Voluntary: Firm initiated
City
Bloomington
State
IN
Country
United States
Event id
98495
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