Recall Z-1788-2026
Cook Incorporated · initiated March 5, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
COOK MEDICAL Spectrum Central Venous Catheter Set: Reference Part Number C-UDLM-401J-ABRM-HC, Order Number G43983; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, Order Number G24754; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, Order Number G43986; Reference Part Number C-UDLM-401J-PED-ABRM-HC, Order Number G43984; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, Order Number G24752; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, Order Number G43985; Reference Part Number C-UDLM-501J-ABRM-HC, Order Number G43995; Reference Part Number C-UDLM-501J-PED-ABRM-HC, Order Number G43996; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, Order Number G43997; Reference Part Number C-UDLM-801J-ABRM-HC, Order Number G50817; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, Order Number G51537; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, Order Number G51539; Reference Part Number C-UTLM-501J-ABRM-HC, Order Number G44005; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, Order Number G24803; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, Order Number G44008; Reference Part Number C-UTLM-501J-PED-ABRM-HC, Order Number G44006; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, Order Number G44007; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, Order Number G24765; Reference Part Number C-UTLM-701J-ABRM-HC-RD, Order Number G47825; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, Order Number G24809; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, Order Number G53599; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, Order Number G47827; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, Order Number G47829; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, Order Number G24810.
Codes / lots: Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260424(10)15569919, Lot Number 15569919; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260403(10)15520378, Lot Number 15520378; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15487727, Lot Number 15487727; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)260227(10)15484947, Lot Number 15484947; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)16617145, Lot Number 16617145; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617419, Lot Number NS16617419; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280527(10)NS16617420, Lot Number NS16617420; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620091, Lot Number NS16620091; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620092, Lot Number NS16620092; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620093, Lot Number NS16620093; Reference Part Number C-UDLM-401J-ABRM-HC, UDI…
Reason for recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
FDA-determined cause: Incorrect or no expiration date
Action taken
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.
Details
- Recall number
- Z-1788-2026
- Initiated
- March 5, 2026
- Posted by FDA
- April 6, 2026
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Quantity
- 5080 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Cook Incorporated, Bloomington, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1775-2026 Class II | COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1776-2026 Class II | COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1777-2026 Class II | COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1778-2026 Class II | COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1779-2026 Class II | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1780-2026 Class II | COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1781-2026 Class II | COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1782-2026 Class II | COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1783-2026 Class II | COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1784-2026 Class II | COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1785-2026 Class II | Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1786-2026 Class II | COOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1787-2026 Class II | COOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1789-2026 Class II | COOK MEDICAL Spectrum Central Venous Tray: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1790-2026 Class II | COOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1791-2026 Class II | COOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |
| Z-1792-2026 Class II | COOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number…Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 03/05/2026Open, Classified |