Shiley recallZ-2261-2026 · Covidien LLC · initiated Apr 15, 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 Covidien LLC 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
Due to customer complaint regarding incorrect display box labeling.
FDA root cause category: Process control
What the company is doing
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 [email protected] even if they do not have unused inventory. For questions - contact Medtronic Representative or Customer Service at 800-962-9888.
Recall details
- Recall number
- Z-2261-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 15, 2026
- Posted by the FDA
- May 29, 2026
- Recalling firm
- Covidien LLC
- Quantity
- 1,002
- Product code
- JOH
- FDA submissions
- K812302
- 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.
Product description
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code: 60884522007028 The devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable inner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley Tracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of polyvinyl chloride.
Code information (models, lots, serial numbers)
Product Number: 6FEN UDI-DI code: 60884522007028 Lot Number: 25H0868JZX
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Shiley 6FENCovidien LP · Tube tracheostomy and tube cuff1 recall106 reports
Product lines
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.
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