Recall of Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set

Source: FDA · Worldwide

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Cook Incorporated is voluntarily recalling 476 units of the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set due to incorrect expiration dates on the labels.

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 the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set because the products were labeled with expiration dates that exceed the true shelf life.

Which Products Are Affected

The affected products include the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set with the following details: Reference Part Number C-TCCSB-500-UNI (Order Number G32193) and Reference Part Number C-TCCSB-500-UNI-01 (Order Number G47665). A total of 476 units are affected, with specific lot numbers such as NS16189671, 16191668, 16195472, 16195467, 16191666, 16191677, 16191661, 16200360, 16185929, 16237917, 16191674, 16191671, 16193388, 16193387, 16191667, 16195473, 16191662, 16191689, 16195468, and 16271019. The products have UDIs like (01)00827002321939(17)270803(10)NS16189671 and others as specified. Distribution was worldwide.

What You Should Do

Consumers with the affected products should follow the firm's initial notifications, which were made via email, fax, letter, press release, telephone, or visit, for instructions on returns or replacements. Contact Cook Incorporated at their address: 750 N Daniels Way, Bloomington, IN 47404-9120.

Why This Matters

This recall addresses potential risks from using products past their actual shelf life, which could impact their reliability in medical emergencies.

Source

FDA recall notice: Z-1785-2026

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 476 units of the Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set due to incorrect expiration dates on the labels.
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.