Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the outer cannula of the device, which could cause respiratory failure, aspiration, unspecified tissue injury, aspiration, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
Take action
Contact the company
📍Recalling firmCovidien6135 Gunbarrel Ave · Boulder, CO 80301-3214
✎ GovInfoNow plain-language explainer
Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes with TaperGuard Cuff Reusable Inner Cannula (REF: 7CN80R) because a flange may disconnect from the outer cannula, risking respiratory failure, aspiration, or death. This is a serious hazard that requires immediate attention. Read more at govinfonow.com/recall/52741-covidien-shiley-tracheostomy-tube-recall-risk-of-respiratory-failure.
“Covidien Shiley Tracheostomy Tube Recall: Risk of Respiratory Failure.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52741-covidien-shiley-tracheostomy-tube-recall-risk-of-respiratory-failure. Based on FDA recall #Z-1390-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1390-2025%22&limit=1).
The FDA announced on Feb. 26, 2025, that Covidien is recalling Shiley Adult Flexible Tracheostomy Tubes with TaperGuard Cuff Reusable Inner Cannula because the flange may disconnect from the outer cannula. This defect could cause respiratory failure, aspiration, tissue injury, infection, bronchospasm, treatment delays or death.
Distribution: France, Germany, Ireland, Italy, Lithuania, Portugal, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Taiwan
The hazard
The tracheostomy tube's flange may disconnect from the outer cannula. According to the FDA, this could cause respiratory failure, aspiration, unspecified tissue injury, respiratory tract infection, bronchospasm, a delay to treatment and/or death.
Context
GovInfoNow's records show Covidien has 14 other recalls on record since March 5, 2021. Other recent recalls of similar products include Covidien Bedside SpO2 Monitor (June 23, 2025), Covidien Newport HT70 Ventilator (May 21, 2025) and Covidien - Medical Devices & Surgical Products (July 9, 2024). Other recent recalls of similar products include Covidien Shiley Tracheostomy Tube (April 15, 2026), Medline Intubation Tray (Dec. 24, 2025) and Elekta Geneva Brachytherapy Applicator (April 3, 2026).
How to tell if you have this one
Look for the product name 'Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner Cannula' and the reference number 7CN80R. The tube may have a lot number starting with 202405258X and expire by June 1, 2029.
Brand
Covidien
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the recalled tracheostomy tube as it may disconnect and cause serious harm.
How this recall unfolded
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1390-2025 (February 26, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1390-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.