Cook Medical Approach CTO-6 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
This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
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-1775-2026
- 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
- 15 units
- Made in
- United States
- Lot / code info
- UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005
- UPC codes
- 00827002507869
Products covered by this recall
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Check your product
The notice names 2 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.
- 00827002507869
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 15288005 — 15 units
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 — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- 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.
- Report device problems to the FDA through MedWatch.
Replacements, repairs and reimbursement
Device remedies run through the supply chain, so the route depends on who sold you the unit.
- Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
- If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
- Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
- Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.
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 00827002507869; lot code 15288005 — 15 units. 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?
Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
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