Cook Approach Hydro ST Micro Wire Guide: Incorrect Expiration Dates
Cook recalls Approach Hydro ST Micro Wire Guides with incorrect expiration dates on labels. Affected units include specific catalog prefixes and part numbers. Consumers should check labels for correct expiration dates.
Lower-risk recall
Affected device lots have labels that state the incorrect expiration dates.
Contact the company
What happened, in plain English
Cook is recalling certain Approach Hydro ST Micro Wire Guides because some units have incorrect expiration dates on their labels. This could lead to confusion about when the product is safe to use, potentially causing safety issues if the product is used after its expiration date. Read more at govinfonow.com/recall/53781-cook-approach-hydro-st-micro-wire-guide-incorrect-expiration-dates.
Source Summary by GovInfoNow · govinfonow.com/recall/53781-cook-approach-hydro-st-micro-wire-guide-incorrect-expiration-dates · Updated September 23, 2026 · FDA enforcement record: FDA #Z-0347-2025
Cite this page
“Cook Approach Hydro ST Micro Wire Guide: Incorrect Expiration Dates.” GovInfoNow, updated September 23, 2026. https://govinfonow.com/recall/53781-cook-approach-hydro-st-micro-wire-guide-incorrect-expiration-dates. Based on FDA recall #Z-0347-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0347-2025%22&limit=1).
Why it’s dangerous
The product has labels that state incorrect expiration dates. This means users might think the device is still safe to use when it has expired, potentially leading to safety issues if the device is used after its expiration date.
Who’s affected
Users of the Approach Hydro ST Micro Wire Guides with specific catalog prefixes and part numbers listed in the recall. Those most at risk are healthcare professionals who rely on these devices for medical procedures.
How to tell if you have this one
Check the label on the device for the catalog prefix HMW and part numbers HMW-14-135-ST, HMW-14-190-ST, or HMW-14-300-ST. Also look for specific lot numbers listed in the recall notice.
- Brand
Cook- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Worldwide - US Nationwide distribution.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0346-2025 | Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G; RPN /UDI-DI/ Lots: CMW-14-190-12G/ 00827002507876/ 15763571 15773059 15783003 15885574 NS15821244 NS15849650 CMW-14-190-18G/ 00827002507883/ 15763579 15769462 15802931 15811662 15898546 15925115 15943888 15974443 15802931X NS15849651 CMW-14-190-25G/ 00827002507890/ 15778254 15791923 15802932 15849652 15891914 15891915 15995205 CMW-14-190-6G/ 00827002507869/ 15800162 15907477 16018911 CMW-14-300-12G/ 00827002507913/ 15718982 15763552 15763561 15763577 15763604 15763605 15794897 15802924 15858395 15858399 15885578 15891916 15898543 15915909 15943896 15945778 15952518 15956556 15958706 NS15843567 NS15892396 CMW-14-300-18G/ 00827002507920/ 15718980 15763553 15763563 15763585 15765959 15794895 15802926 15802933 15835853 15858397 15863270 15891906 15891910 15892397 15900750 15913326 15915903 15915904 15945777 15945781 15958704 15971786 NS15773060 NS15811659 NS15898544 NS15898545 NS15945782 CMW-14-300-25G/ 00827002507937/ 15718981 15731211 15763580 15763591 15763609 15765960 15794896 15800156 15811660 15835856 15863271 15885579 15891911 15892398 15915902 15943887 15943891 15943892 15943897 16018907 NS15821243 NS15945783 NS15974440 NS16006214 NS16025239 CMW-14-300-6G/ 00827002507906/ 15763597 15778251 15794898 15858400 15891908 15907474 15925117 15995202 NS15800160 NS15829388 NS15849653 NS16008457 | 2,005 US; 1,145 OUS |
| Z-0347-2025 | Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers: HMW-14-135-ST HMW-14-190-ST HMW-14-300-ST; RPN /UDI-DI/ Lots: HMW-14-135-ST/ 00827002529373/ 15735501 15765954 15863269 15874634 15907468 15943872 15943886 15971771 15974437 16012937 15971771X 16012937X HMW-14-190-ST/ 00827002529380/ 15726043 15726044 15765947 15765955 15778260 15800165 15800166 15811656 15811657 15821245 15829376 15831156 15835857 15849644 15858389 15874633 15885580 15891903 15894221 15894222 15907469 15908739 15943873 15943874 15943881 15943882 15945799 15945801 15952502 15971778 15971779 15979320 15988603 15999088 15999089 16018914 16018917 16018919 15874633X 16018919X NS15765956 NS15769470 NS15783001 NS15794893 NS15802918 NS15821246 NS15835858 NS15849643 NS15915900 NS16029493 HMW-14-300-ST/ 00827002529397/ 15718978 15718979 15720963 15726042 15726045 15731209 15731210 15735502 15765946 15765948 15765949 15765950 15765951 15765952 15765953 15769463 15769464 15769465 15769466 15769467 15769469 15778257 15778258 15778259 15794890 15794891 15800167 15802919 15802920 15802921 15811658 15816909 15816910 15821248 15821250 15829375 15829377 15831157 15831159 15843561 15845744 15845745 15845746 15858390 15858391 15858392 15863266 15863267 15863268 15879455 15885581 15885582 15885583 15885584 15891901 15891902 15892394 15894223 15894224 15894225 15894226 15894227 15898542 15902068 15902069 15902070 15925109 15925110 15925111 15925113 15925114 15943875 15943876 15943877 15943878 15943879 15943880 15943883 15943884 15943885 15945800 15952500 15952501 15958703 15971772 15971773 15971774 15971775 15971776 15971777 15971780 15979321 15988604 15995198 15995199 15995200 16004716 16004717 16004718 16004719 16004720 16004721 16010288 16010289 16018915 16018918 16025193 16029492 16042142 16042143 16042144 16042145 15726042X 15843560X 15902070X 15943885X NS15720964 NS15766147 NS15769468 NS15794892 NS15800168 NS15802922 NS15821247 NS15821249 NS15845747 NS15856480 NS15858393 NS15892395 NS16018395 | 5,953 US; 2,528 OUS |
What to do — step by step
Check Label Expiration Date
Verify the expiration date on the device label matches the correct date provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 43 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-0347-2025 (October 8, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0347-2025 to see it in context.
- Plain-language summary written by qwen3:4b on September 23, 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.