Cook Medical Approach CTO-12 Micro Wire Guide Recall
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Cook Incorporated is recalling 49 units of its Approach CTO-12 Micro Wire Guide devices due to incorrect expiration dates on the labels, affecting worldwide distribution.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 23, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Cook Incorporated is recalling certain lots of the Approach CTO-12 Micro Wire Guide because the products were labeled with expiration dates that exceed the true shelf life, potentially affecting their safety and effectiveness.
Which Products Are Affected
The affected products include: Reference Part Number CMW-14-190-12G (Order Number G50787) and Reference Part Number CMW-14-300-12G (Order Number G50791). The recall involves 49 units with specific codes: For CMW-14-190-12G, UDI (01)00827002507876(17)260509(10)15885574X, Lot Number 15885574X; and UDI (01)00827002507876(17)281203(10)15783003X, Lot Number 15783003X. For CMW-14-300-12G, UDI (01)00827002507913(17)260227(10)15416547, Lot Number 15416547. The distribution is worldwide, and the recall number is Z-1776-2026.
What You Should Do
Consumers who have these products should contact Cook Incorporated for instructions, as the recall was initiated voluntarily by the firm through methods such as email, fax, letter, press release, telephone, or visit.
Why This Matters
This recall highlights potential risks with medical devices due to labeling errors, which could lead to ineffective treatment if products are used beyond their actual shelf life. It affects a small number of units but underscores the importance of accurate labeling in healthcare.
Source
FDA recall notice for event ID 98495, available through the FDA website.
Original source: FDA Official Notice ↗
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