Class IIOngoingZ-1789-2026

Cook Incorporated recalls COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-A…

Cook IncorporatedBloomington, IN, United StatesReported Apr 15, 2026 · 3 months ago

By Taylor Coteus

Legal News Analyst · Apr 15, 2026

Reason for recall

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

COOK MEDICAL Spectrum¿ Central Venous Tray: Reference Part Number C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD, Order Number G44800; Reference Part Number C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD, Order Number G44809; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-FST-A-RD, Order Number G44806; Reference Part Number C-UTLMYJ-701J-RSC-ABRM-HC-IHI-FST-A-RD, Order Number G44807.

Lot / code information

UDI: (01)00827002448001(17)280512(10)NS16597252
Lot #: NS16597252; C-UQLMYJ-1001J-RSC-ABRM-HC-FST-A-RD
UDI: (01)00827002448001(17)280513(10)NS16600633
Lot #: NS16600633; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD
UDI: (01)00827002448094(17)280327(10)16530788
Lot #: 16530788; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD
UDI: (01)00827002448094(17)280401(10)16537255
Lot #: 16537255; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD
UDI: (01)00827002448094(17)280417(10)16562522
Lot #: 16562522; C-UTLMYJ-701J-ABRM-HC-IHI-FST-A-RD

What the firm is doing

Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.

DistributionShow details

Worldwide distribution.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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