Cook Medical recalled 75 CTO-18 Micro Wire Guide devices distributed worldwide. The recall cites expiration date labeling that exceeds the true shelf life. Healthcare providers should stop using affected lots immediately and follow manufacturer instructions.
Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cook Incorporated or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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Cook Medical CTO-18 Micro Wire Guides are used to facilitate endovascular procedures by guiding catheters and devices through vessels.
Mislabeled expiration dates could lead to the use of devices that may not meet shelf-life guarantees, potentially affecting sterility or performance.
This recall is not identified as part of a broader industry pattern.
Immediate action required for any affected units to avoid potential use of expired devices.
FDA enforcement recall page and Cook Medical recall communications
Recall notice date 2026-03-05; status active as of 2026-04-15; replacements or refunds handled per Cook communications
Keep copies of all recall notices, supplier communications, and any replacement receipts
Product: CTO-18 Micro Wire Guide. Reference Part Numbers: CMW-14-190-18G (Lot 15898546X) and CMW-14-300-18G (Lot 15220204). Order Numbers: G50788 and G50792. Distribution: Worldwide. Recall date: 2026-03-05. Status: Active. Quantity: 75 units.
No injuries or incidents are described in the recall notice.
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