Cook Approach CTO Micro Wire Guide: Incorrect Expiration Dates
Cook recalls Approach CTO Micro Wire Guide with incorrect expiration dates on labels. Affected lots may have safety risks if used beyond expiration.
Lower-risk recall
Devices from the affected device lots have labels that state the incorrect expiration dates.
Contact the company
What happened, in plain English
Cook is recalling its Approach CTO Micro Wire Guide due to labels with incorrect expiration dates. This could lead to using the product after it has expired, potentially causing safety issues. Read more at govinfonow.com/recall/53717-cook-approach-cto-micro-wire-guide-incorrect-expiration-dates.
Source Summary by GovInfoNow · govinfonow.com/recall/53717-cook-approach-cto-micro-wire-guide-incorrect-expiration-dates · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0499-2025
Cite this page
“Cook Approach CTO Micro Wire Guide: Incorrect Expiration Dates.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53717-cook-approach-cto-micro-wire-guide-incorrect-expiration-dates. Based on FDA recall #Z-0499-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0499-2025%22&limit=1).
Why it’s dangerous
The product has labels with incorrect expiration dates, which means it might be used after the expiration date. This could lead to reduced effectiveness or safety issues if the product is no longer stable or safe after expiration.
Who’s affected
Users of the Approach CTO Micro Wire Guide who purchased it with the affected lot numbers are likely affected. Medical professionals using the product for procedures are at higher risk if the expiration date is incorrect.
How to tell if you have this one
Check the label for the product name 'Approach CTO Micro Wire Guide' and lot numbers NS15635381, NS15618280, NS15466311, NS15212224, or NS14992020. The product also has a unique identifier UDI-DI: 00827002507890.
- Brand
Cook- Category
Medical device
What to do — step by step
Check Expiration Date
Look for the expiration date on the product label to ensure it matches the correct date.
How this recall unfolded
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0499-2025 (October 14, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0499-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.