Lower riskMedical device recall · FDA · Published August 28, 2020
Smiths Medical Bivona Tracheostomy Tube Has Incorrect Size Label
Smiths Medical recalls Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes due to incorrect size labeling on the label, which could lead to improper fitting.
“Smiths Medical Bivona Tracheostomy Tube Has Incorrect Size Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64421-smiths-medical-bivona-tracheostomy-tube-has-incorrect-size-label. Based on FDA recall #Z-2946-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2946-2020%22&limit=1).
The FDA announced on Aug. 28, 2020, that Smiths Medical ASD Inc. is recalling Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes because the label displays an incorrect size for the device.
The hazard is that the label has the incorrect size for the tracheotomy tube.
Context
GovInfoNow's records show Smiths Medical ASD, Inc. has 73 other recalls on record since June 5, 2017. Other recent recalls of similar products include Covidien Shiley Tracheostomy Tube Recall: Incorrect Box Labeling (April 15, 2026), W L Gore GORE VIABIL Short Wire Biliary Endoprosthesis Recall: Incorrect Labeling Risk (May 22, 2026), and Grace Medical recalls Stapes Prosthesis due to incorrect labeling (April 3, 2026).
How to tell if you have this one
Check for the Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube with lot number 3952216. The product is intended for tracheotomized patients and may be reprocessed up to 10 times.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Label Size
Verify the size on the label matches the intended tube size for your patient.
Where it went and when
Where it was distributed
Distributed in Connecticut.
Listed by the agency
Not listed
FDA distribution: “US Distribution to state of: CT” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Connecticut.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-2946-2020 (August 28, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2946-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.