Covidien Shiley Tracheostomy Tube Recall: Incorrect Box Labeling
Covidien recalls Shiley Tracheostomy Tubes with incorrect box labeling. Affected units may have mislabeled packaging, but no safety hazard exists. Contact for details.
Lower-risk recall
Due to customer complaint regarding incorrect display box labeling.
Contact the company
What happened, in plain English
Covidien is recalling Shiley Tracheostomy Tubes with incorrect box labeling. This issue does not pose a safety risk to users, as the product functions normally but has mislabeled packaging. Read more at govinfonow.com/recall/49462-covidien-shiley-tracheostomy-tube-recall-incorrect-box-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/49462-covidien-shiley-tracheostomy-tube-recall-incorrect-box-labeling · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2261-2026
Cite this page
“Covidien Shiley Tracheostomy Tube Recall: Incorrect Box Labeling.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49462-covidien-shiley-tracheostomy-tube-recall-incorrect-box-labeling. Based on FDA recall #Z-2261-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2261-2026%22&limit=1).
Why it’s dangerous
The hazard is due to incorrect display box labeling, which could lead to confusion about the product's specifications. However, the tubes themselves are safe and function properly for airway management.
Who’s affected
Users of Shiley Tracheostomy Tubes with the specific model and UDI-DI code 60884522007028 are affected. Patients and caregivers using these tubes may need to verify the labeling.
How to tell if you have this one
Check for the product model '6FEN' and UDI-DI code '60884522007028' on the packaging. The recall is for devices with this specific labeling error.
- Brand
Covidien- Category
Medical device
What to do — step by step
Check Labeling
Verify the product model and UDI-DI code on the packaging to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 56 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-2261-2026 (April 15, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2261-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.