COOK MEDICAL Approach CTO-18 Micro Wire Guide recall (Cook Incorporated)
Medical deviceClass IIOngoing
Summary: Cook Incorporated is recalling 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. Reason: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
What is being recalled
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
Why
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution.
How to tell if yours is affected
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 to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1777-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 5, 2026 |
| Reported | April 15, 2026 |
| Company | Cook Incorporated |
| Company location | Bloomington, IN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 75 units |
More recalls from Cook Incorporated · all medical device recalls · recalls from March 2026