Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
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
Why it was recalled
Affected device lots have labels that state the incorrect expiration dates.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
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
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
Worldwide - US Nationwide distribution.
Recall record
- Recalling firm
- Cook Incorporated
- Product type
- Devices
- Recall number
- Z-0346-2025
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Letter
- Origin
- Bloomington, IN
- Recall initiated
- 2024-10-08
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0346-2025 · Source: openFDA enforcement.