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CLASS II · ModerateFDA

Cook Incorporated recalls COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G

📅 Mar 5, 2026 · 📍 See notice
Recalling company
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
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Mar 5, 2026
Reported
Apr 15, 2026
Distribution
Worldwide distribution.
Status
Ongoing
Quantity
49 units
Lot / codes
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.
Company location
Bloomington, IN
Recall type
Voluntary: Firm initiated
Recall number
Z-1776-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1776-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.