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COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792

Class II
Recalling firm
Cook Incorporated
Reason for recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Affected products (lot / model / serial)
Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)290214(10)15898546X, Lot Number 15898546X; Reference Part Number CMW-14-190-18G, UDI (01)00827002507883(17)270115(10)15660224, Lot Number 15660224; Reference Part Number CMW-14-300-18G, UDI (01)00827002507920(17)260718(10)15220204, Lot Number 15220204.
Units affected
75 units
Distribution pattern
Worldwide distribution.
Firm location
Bloomington, IN, United States
Recall type
Voluntary: Firm initiated
How the firm notified customers
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type
Devices
Status
Ongoing
Recall number
Z-1777-2026
Recall initiated
March 5, 2026
FDA classification date
April 6, 2026
FDA report date
April 15, 2026
FDA event ID
98495
Last updated on HTM Vibe
July 24, 2026
View on openFDA