Recall of Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set
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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.
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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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