Cook Medical Approach CTO-12 Micro Wire Guide: Reference recall: Products from the affected device lots were labeled with expiration dates
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
The hazard: Device safety concern
The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
What the notice says: Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-1776-2026
- Published
- April 15, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Cook Incorporated
- Product type
- Medical devices
- Units affected
- 49 units
- Made in
- United States
- Lot / 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.
- UPC codes
- 00827002507876, 00827002507913
Products covered by this recall
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
Check your product
The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00827002507876
- 00827002507913
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 15885574X
- 15783003X
- 15416547. — 49 units
Model or item number
On the rating label, the box or the instruction sheet.
- UDI
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Cook Incorporated — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
Who pays for a device recall
The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.
- If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
- Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
- If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
- Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.
Company contact: Cook Incorporated — 750 N Daniels Way, Bloomington, IN, 47404-9120
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Cook Incorporated medical devices recalled?
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00827002507876, 00827002507913; lot code 15885574X, 15783003X, 15416547. — 49 units; model number UDI. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
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