Cook Spectrum recallZ-1788-2026 · Cook Incorporated · initiated Mar 5, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
FDA root cause category: Incorrect or no expiration date
What the company 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 ([email protected]). 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: [email protected]. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Recall details
- Recall number
- Z-1788-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 5, 2026
- Posted by the FDA
- Apr 6, 2026
- Recalling firm
- Cook Incorporated
- Quantity
- 5080 units
- Product code
- FOZ
- FDA submissions
- K033843, K081113
- Distribution
- Worldwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
Show the full code information (14k characters)
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 (01)00827002439832(17)280528(10)NS16620094, Lot Number NS16620094; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620414, Lot Number NS16620414; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620415, Lot Number NS16620415; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280528(10)NS16620416, Lot Number NS16620416; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622160, Lot Number NS16622160; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622161, Lot Number NS16622161; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622162, Lot Number NS16622162; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622163, Lot Number NS16622163; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622164, Lot Number NS16622164; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622165, Lot Number NS16622165; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622166, Lot Number NS16622166; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622167, Lot Number NS16622167; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280529(10)NS16622168, Lot Number NS16622168; Reference Part Number C-UDLM-401J-ABRM-HC, UDI (01)00827002439832(17)280602(10)NS16625835, Lot Number NS16625835; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260619(10)NS15668028, Lot Number NS15668028; Reference Part Number C-UDLM-401J-ABRM-HC-CAH, UDI (01)00827002247543(17)260227(10)NS15473245, Lot Number NS15473245; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282739, Lot Number NS15282739; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15282763, Lot Number NS15282763; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)260213(10)NS15583873, Lot Number NS15583873; Reference Part Number C-UDLM-401J-LSC-ABRM-HC, UDI (01)00827002439863(17)280714(10)NS16692824, Lot Number NS16692824; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15557442, Lot Number 15557442; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260314(10)15520367, Lot Number 15520367; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260220(10)15518160, Lot Number 15518160; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)260327(10)15594051, Lot Number 15594051; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280426(10)16576182, Lot Number 16576182; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280527(10)16617146, Lot Number 16617146; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280529(10)16622169, Lot Number 16622169; Reference Part Number C-UDLM-401J-PED-ABRM-HC, UDI (01)00827002439849(17)280612(10)16642446, Lot Number 16642446; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260327(10)NS15583886, Lot Number NS15583886; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260314(10)NS15501647, Lot Number NS15501647; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)260220(10)NS15514024, Lot Number NS15514024; Reference Part Number C-UDLM-401J-PED-ABRM-HC-CAH, UDI (01)00827002247529(17)280331(10)NS16534729, Lot Number NS16534729; Reference Part Number C-UDLM-401J-RSC-ABRM-HC, UDI (01)00827002439856(17)280423(10)16572552, Lot Number 16572552; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280311(10)16505314, Lot Number 16505314; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280412(10)16554636, Lot Number 16554636; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280416(10)16559432, Lot Number 16559432; Reference Part Number C-UDLM-501J-ABRM-HC, UDI (01)00827002439955(17)280423(10)16572551, Lot Number 16572551; Reference Part Number C-UDLM-501J-PED-ABRM-HC, UDI (01)00827002439962(17)260619(10)NS15582078, Lot Number NS15582078; Reference Part Number C-UDLM-501J-RSC-ABRM-HC, UDI (01)00827002439979(17)280428(10)NS16577963, Lot Number NS16577963; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454754, Lot Number NS16454754; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280206(10)NS16454756, Lot Number NS16454756; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280505(10)NS16587983, Lot Number NS16587983; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280521(10)NS16612427, Lot Number NS16612427; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280528(10)NS16620419, Lot Number NS16620419; Reference Part Number C-UDLM-801J-ABRM-HC, UDI (01)00827002508170(17)280623(10)NS16657119, Lot Number NS16657119; Reference Part Number C-UQLM-1001J-ABRM-HC-RD, UDI (01)00827002515376(17)260417(10)15478180, Lot Number 15478180; Reference Part Number C-UQLM-1001J-RSC-ABRM-HC-RD, UDI (01)00827002515390(17)280402(10)16539971, Lot Number 16539971; Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260626(10)15628883, Lot Number 15628883; Reference Part Number C-UTLM-501J-ABRM-HC, UDI (01)00827002440050(17)260130(10)15496521, Lot Number 15496521; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15660282, Lot Number NS15660282; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)260626(10)NS15628880, Lot Number NS15628880; Reference Part Number C-UTLM-501J-ABRM-HC-CAH, UDI (01)00827002248038(17)280505(10)NS16588033, Lot Number NS16588033; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280402(10)16539976, Lot Number 16539976; Reference Part Number C-UTLM-501J-LSC-ABRM-HC, UDI (01)00827002440081(17)280416(10)NS16493943XX, Lot Number NS16493943XX; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260710(10)NS15643882, Lot Number NS15643882; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260626(10)NS15683399, Lot Number NS15683399; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15559871, Lot Number NS15559871; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260327(10)NS15597521, Lot Number NS15597521; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)260213(10)NS15489151, Lot Number NS15489151; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280303(10)NS16490614, Lot Number NS16490614; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280304(10)NS16493940, Lot Number NS16493940; Reference Part Number C-UTLM-501J-PED-ABRM-HC, UDI (01)00827002440067(17)280417(10)NS16562685, Lot Number NS16562685; Reference Part Number C-UTLM-501J-RSC-ABRM-HC, UDI (01)00827002440074(17)260327(10)15484937, Lot Number 15484937; Reference Part Number C-UTLM-501J-RSC-ABRM-HC-CAH, UDI (01)00827002247659(17)280328(10)NS16532973, Lot Number NS16532973; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15550737, Lot Number 15550737; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15553839, Lot Number 15553839; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260417(10)15565537, Lot Number 15565537; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260327(10)15520384, Lot Number 15520384; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)260713(10)15655329, Lot Number 15655329; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280318(10)16514973, Lot Number 16514973; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280331(10)16535286, Lot Number 16535286; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280411(10)16554189, Lot Number 16554189; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280414(10)16556349, Lot Number 16556349; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280430(10)16580721, Lot Number 16580721; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280502(10)16584953, Lot Number 16584953; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625683, Lot Number 16625683; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280602(10)16625826, Lot Number 16625826; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280606(10)16634342, Lot Number 16634342; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636211, Lot Number 16636211; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280609(10)16636220, Lot Number 16636220; Reference Part Number C-UTLM-701J-ABRM-HC-RD, UDI (01)00827002478251(17)280611(10)16639240, Lot Number 16639240; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280318(10)16514972, Lot Number 16514972; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280328(10)16532975, Lot Number 16532975; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280412(10)16554638, Lot Number 16554638; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280417(10)16562523, Lot Number 16562523; Reference Part Number C-UTLM-701J-ABRM-HC-RD-CAH, UDI (01)00827002248090(17)280429(10)16579251, Lot Number 16579251; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260410(10)15518162, Lot Number 15518162; Reference Part Number C-UTLM-701J-ABRM-HC-RD-P, UDI (01)00827002535992(17)260822(10)15586027, Lot Number 15586027; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280401(10)NS16537254, Lot Number NS16537254; Reference Part Number C-UTLM-701J-LSC-ABRM-HC-RD, UDI (01)00827002478275(17)280501(10)NS16582898, Lot Number NS16582898; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15660266, Lot Number 15660266; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15655331, Lot Number 15655331; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)260403(10)15683408, Lot Number 15683408; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556179, Lot Number 16556179; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280414(10)16556350, Lot Number 16556350; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625673, Lot Number 16625673; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280602(10)16625817, Lot Number 16625817; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678414, Lot Number 16678414; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678420, Lot Number 16678420; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280702(10)16678428, Lot Number 16678428; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683763, Lot Number 16683763; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD, UDI (01)00827002478299(17)280708(10)16683788, Lot Number 16683788; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)260403(10)15687199, Lot Number 15687199; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280412(10)16554639, Lot Number 16554639; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280415(10)16557470, Lot Number 16557470; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280602(10)16625682, Lot Number 16625682; Reference Part Number C-UTLM-701J-RSC-ABRM-HC-RD-CAH, UDI (01)00827002248106(17)280612(10)16642011, Lot Number 16642011.
Devices named in this recall
24 devices in the FDA device registry whose identifier appears in the recall's code information.
- Cook Spectrum G47829Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall81 reports
- Cook Spectrum G47825Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall21 reports
- Cook Spectrum G50817Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall16 reports
- Cook Spectrum G53599Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall10 reports
- Cook Spectrum G47827Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall8 reports
- Cook Spectrum G51539Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall4 reports
- Cook Spectrum G43995Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall2 reports
- Cook Spectrum G43983Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall1 report
- Cook Spectrum G51537Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall1 report
- Cook Spectrum G24752Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G24754Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G24765Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G24803Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G24809Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G24810Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G43984Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G43985Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G43986Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G43996Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G43997Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G44005Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G44006Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G44007Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- Cook Spectrum G44008Cook Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98495).
- Z-1775-2026 · Open, ClassifiedCOOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
- Z-1776-2026 · Open, ClassifiedCOOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791
- Z-1777-2026 · Open, ClassifiedCOOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792
- Z-1778-2026 · Open, ClassifiedCOOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4.0-21J-1-12, Order Number G58419
- Z-1779-2026 · Open, ClassifiedCOOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA…
- Z-1780-2026 · Open, ClassifiedCOOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-…
- Z-1781-2026 · Open, ClassifiedCOOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Reference Part Number C-PTIS-100-HC, Orde…
- Z-1783-2026 · Open, ClassifiedCOOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-…
- Z-1784-2026 · Open, ClassifiedCOOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
- Z-1785-2026 · Open, ClassifiedMelker 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 …
- Z-1786-2026 · Open, ClassifiedCOOK MEDICAL Multipurpose Drainage Catheter: Reference Part Number ULT8.5-38-25-P-CLMS-8-RH-FS, Order Number G29775
- Z-1787-2026 · Open, ClassifiedCOOK MEDICAL NCompass Nitinol Stone Extractor: Reference Part Number C-NTSE-2.4-115-NC3, Order Number G36250; Reference Part Number C-NTSE-2.4-115-NCT4, Order Number G36251.
- Z-1789-2026 · Open, ClassifiedCOOK 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-R…
- Z-1790-2026 · Open, ClassifiedCOOK MEDICAL Thal-Quick Chest Tube Tray: Reference Part Number C-TQTSY-3200, Order Number G07242
- Z-1791-2026 · Open, ClassifiedCOOK MEDICAL Wayne Pneumothorax Set: Reference Part Number C-UTPT-1020-WAYNE-IMH, Order Number G56532; Reference Part Number C-UTPT-1400-WAYNE-112497-IMH, Order Number G56535.
- Z-1792-2026 · Open, ClassifiedCOOK MEDICAL Wayne Pneumothorax Tray: Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number G56537; Reference Part Number C-UTPTY-1400-WAYNE-112497-IMH, Order Number …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page