COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intende

FDA device recall Z-2261-2026 · posted 2026-05-29 · Open, Classified

Recall details

Recalling firm

Covidien LLC

Reason for recall

Due to customer complaint regarding incorrect display box labeling.

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

JOH

Quantity affected

1,002

Distribution

Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.

Date initiated

2026-04-15

Date posted

2026-05-29

Location

Boulder, CO

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