Approach CTO Micro Wire Guide, Guide Wire
Medical device recall Z-0346-2025. Published in FDA’s Enforcement Report on Nov 20, 2024.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 20, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 2,005 US; 1,145 OUS how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Affected device lots have labels that state the incorrect expiration dates.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
2,005 US; 1,145 OUS, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,310 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide - US Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 8, 2024.
- FDA classified it on Nov 8, 2024.
- FDA’s Enforcement Report published it on Nov 20, 2024.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Incorporated, of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.