Recall of COOK MEDICAL Approach CTO-18 Micro Wire Guide for Incorrect Expiration Dates

Source: FDA · Worldwide

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Cook Incorporated is voluntarily recalling 75 units of the COOK MEDICAL Approach CTO-18 Micro Wire Guide due to mislabeled expiration dates that exceed the true shelf life.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 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 COOK MEDICAL Approach CTO-18 Micro Wire Guide because the products were labeled with expiration dates that exceed the true shelf life.

Which Products Are Affected

The affected products are the COOK MEDICAL Approach CTO-18 Micro Wire Guide with the following details: Reference Part Number CMW-14-190-18G (Order Number G50788) and Reference Part Number CMW-14-300-18G (Order Number G50792). The recall involves 75 units. Specific codes include: Reference Part Number CMW-14-190-18G with UDI (01)00827002507883(17)290214(10)15898546X and Lot Number 15898546X; Reference Part Number CMW-14-190-18G with UDI (01)00827002507883(17)270115(10)15660224 and Lot Number 15660224; Reference Part Number CMW-14-300-18G with UDI (01)00827002507920(17)260718(10)15220204 and Lot Number 15220204. The products were distributed worldwide.

What You Should Do

Consumers who have the affected products should follow the initial firm notification, which may include email, fax, letter, press release, telephone, or a visit, and contact Cook Incorporated at their address: 750 N Daniels Way, Bloomington, IN 47404-9120, for instructions on returns or refunds. The recall is voluntary and initiated by the firm.

Why This Matters

This recall highlights potential risks from inaccurate labeling on medical devices, affecting 75 units distributed worldwide and emphasizing the need for proper expiration date accuracy to ensure device safety.

Source

This recall information is attributed to the FDA with recall number Z-1777-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Cook Incorporated is voluntarily recalling 75 units of the COOK MEDICAL Approach CTO-18 Micro Wire Guide due to mislabeled expiration dates that exceed the true shelf life.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.