Device recalls

COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786

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

Open, ClassifiedIncorrect or no expiration dateZ-1775-2026
Open FDA's page for this record
Cfres ID
218915
Product res number
Z-1775-2026
Event date initiated
2026-03-05
Event date posted
2026-04-06
Recall status
Open, Classified
Res event number
98495
Product code
DQX
Product description
COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Code info
UDI (01)00827002507869(17)270708(10)15288005, Lot Number 15288005
Firm FEI number
1820334
Recalling firm
Cook Incorporated
Address 1
750 N Daniels Way
City
Bloomington
State
IN
Postal code
47404-9120
Additional info contact
Cook Medical Customer Relations Department 812-457-4500
Reason for recall
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Root cause description
Incorrect or no expiration date
Product quantity
15 units
Distribution pattern
Worldwide distribution.
Action

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.

K numbers
K171897
Harmonized identifiers (openFDA)
Device name
Wire, Guide, Catheter
Medical specialty description
Cardiovascular
Regulation number
870.1330
Device class
2
K number
K193194, K882507, K091385, K153106, K924202, K973845, K871517, K101985, K141295, K954552, K253146, K201690, K260544, K873972, K921702, K010497, K160594, K130588, K922787, K841926, K063695, K151840, K902153, K032411, K201834, K112381, K946240, K083145, K972944, K860430, K042370, K122590, K890807, K903923, K121776, K232578, K880332, K864058, K212167, K123792 +728 more
Registration number
3009564766, 1319211, 3020778, 3030733800, 3020954746, 3004091615, 3009380063, 1223004, 1220452, 2518902, 3010041511, 3014716786, 3009756153, 3030446844, 2134265, 3006082230, 3015173212, 3003768277, 3014162263, 3012050423, 1450662, 2527072, 2030624, 8043892, 3008114965, 3010882065, 3006010712, 3013611763, 3012536737, 3014579161, 1313046, 1721504, 3009211636, 2020394, 3005737652, 1282497, 1225687, 2029214, 3041276591, 2939520 +220 more
FEI number
3009564766, 1319211, 3020778, 3030733800, 3020954746, 3004091615, 3009380063, 1220452, 3001632632, 2518902, 3010041511, 3014716786, 3009756153, 1000512168, 3030446844, 3003407487, 3006082230, 3015173212, 3014162263, 3012050423, 1450662, 2527072, 3002947440, 3002807725, 3008114965, 3002902735, 3006010712, 3013611763, 3012536737, 3014579161, 1313046, 1721504, 3002913962, 3009211636, 2020394, 3002807095, 3005737652, 1282497, 3041276591, 2939520 +219 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.