Covidien LLC recalls COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 6088…

Due to customer complaint regarding incorrect display box labeling.

On 04/15/2026, the firm sent via mail/email an "Urgent Medical Device Recall" Letter to customers informing them that due to a manufacturing process packaging error, correctly manufactured and labeled individual units of the Covidien Shiley" cuffed fenestrated adult tracheostomy tube with reusable inner cannula were inadvertently placed into incorrect display boxes. A customer report indicating that the product display box is incorrectly labeled as item code 6CFN, which corresponds to cuffless devices. The correct item code is 6FEN, and it appears correctly on all other labeling, including the outer carton labels and device tray label. Customers are instructed to: 1. Quarantine all unused product from the affected lot of Covidien Shiley" cuffed fenestrated adult tracheostomy tube with reusable inner cannula. 2. Return all unused product from the affected lot in their inventory to Medtronic, as described in the Customer Confirmation Form. 3. Share this notice with all relevant personnel within their organization, and with any organization to which the potentially affected product from the specified lot has been transferred or distributed. 4. Complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if they do not have unused inventory. For questions - contact Medtronic Representative or Customer Service at 800-962-9888.

• FDA enforcement recordOfficial FDA database entry for Z-2261-2026
• FDA 510(k) clearance · K812302The device's official FDA premarket clearance record
• FDA device classification · JOHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 868.5800The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Covidien LLCSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

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.