FDAHealthMarch 5, 2026
Cook Incorporated — 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
⚠️ Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Is this relevant to me?
- Geography
- Unknown
- Source agency
- FDA
- Category
- Health
- Published
- March 5, 2026
Worldwide distribution.
What's affected?
- Product
- 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
- Brand
- Cook Incorporated
- Lot code
- 15898546X
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 75 units.
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