CLASS II ONGOING Device recall · Reported 15 Apr 2026 · FDA Enforcement Report

Melker Universal Cuffed Emergency Cricothyrotomy Catheter recalled

Cook is recalling Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference. The recall was initiated on 5 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesReference Part Number C-TCCSB-500-UNI, UDI (01)00827002321939(17)270803(10)NS16189671, Lot Number NS16189671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191668, Lot Number 16191668; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195472, Lot Number 16195472; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195467, Lot Number 16195467; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191666, Lot Number 16191666; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191677, Lot Number 16191677; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191661, Lot Number 16191661; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270812(10)16200360, Lot Number 16200360; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270731(10)16185929, Lot Number 16185929; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270904(10)16237917, Lot Number 16237917; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191674, Lot Number 16191674; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191671, Lot Number 16191671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193388, Lot Number 16193388; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193387, Lot Number 16193387; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191667, Lot Number 16191667; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195473, Lot Number 16195473; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191662, Lot Number 16191662; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191689, Lot Number 16191689; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195468, Lot Number 16195468; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270927(10)16271019, Lot Number 16271019.

Quantity recalled476 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1785-2026
FDA event ID: 98495
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Ongoing
Recall initiated: 5 Mar 2026
FDA classified: 6 Apr 2026
Reported: 15 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

5 Mar 2026	Recall initiated by company
6 Apr 2026	Classified by FDA	+32 days
15 Apr 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Product as listed by the FDA

Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part Number C-TCCSB-500-UNI-01, Order Number G47665.

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.

Which lots are affected?

Reference Part Number C-TCCSB-500-UNI, UDI (01)00827002321939(17)270803(10)NS16189671, Lot Number NS16189671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191668, Lot Number 16191668; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195472, Lot Number 16195472; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195467, Lot Number 16195467; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191666, Lot Number 16191666; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191677, Lot Number 16191677; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191661, Lot Number 16191661; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270812(10)16200360, Lot Number 16200360; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270731(10)16185929, Lot Number 16185929; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270904(10)16237917, Lot Number 16237917; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191674, Lot Number 16191674; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191671, Lot Number 16191671; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193388, Lot Number 16193388; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270806(10)16193387, Lot Number 16193387; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191667, Lot Number 16191667; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195473, Lot Number 16195473; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191662, Lot Number 16191662; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270805(10)16191689, Lot Number 16191689; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270807(10)16195468, Lot Number 16195468; Reference Part Number C-TCCSB-500-UNI-01, UDI (01)00827002476653(17)270927(10)16271019, Lot Number 16271019.

Where was it sold?

Worldwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

17 other products · FDA event 98495

This product is part of a recall event; the main page for the event is Medical Arterial Pressure Monitoring Tray, Reference recalled.

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026	CLASS II	Medical Arterial Pressure Monitoring Tray, Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Cook¿ Strange Bile Duct Stone Exploration Set: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Wayne Pneumothorax Set: Reference recalled by Cook Incorporated	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Blue Rhino¿ G2-Multi Percutaneous Tracheostomy recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Approach Cto-18 Micro Wire Guide, Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Spectrum¿ Central Venous Tray: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Spectrum¿ Central Venous Catheter Set: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Approach Cto-6 Micro Wire Guide, Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Thal-Quick Chest Tube Tray: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Blue Rhino G2-Multi Percutaneous Tracheostomy recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Multipurpose Drainage Catheter: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Ciaglia Blue Rhino Percutaneous Tracheostomy recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical NCompass¿ Nitinol Stone Extractor: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Approach Cto-12 Micro Wire Guide: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Wayne Pneumothorax Tray: Reference recalled by Cook Incorporated	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled	Cook	Other	IN
15 Apr 2026	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook	Other	IN

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13 May 2026Device	CLASS I	Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled	Cook	Device Malfunction	Nationwide
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15 Apr 2026Device	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook	Other	IN
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