Lower riskMedical device recall · FDA · Published December 15, 2020
Smiths Medical FlexTend Tracheostomy Tube Recall: Wrong Flange Packaging
Smiths Medical recalls specific FlexTend Tracheostomy Tubes due to potential incorrect packaging with a V-neck flange instead of straight flange. Affected units may need verification.
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
Take action
Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
“Smiths Medical FlexTend Tracheostomy Tube Recall: Wrong Flange Packaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63660-smiths-medical-flextend-tracheostomy-tube-recall-wrong-flange-packaging. Based on FDA recall #Z-0726-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0726-2021%22&limit=1).
Smiths Medical ASD Inc. recalled PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube REF 60PFSS45 due to incorrect packaging, the FDA said on Dec. 15, 2020. The hazard involves a V-neck flange being packaged instead of a straight flange.
A specific model and lot number of Bivona Cuffless FlexTend Tracheostomy Tube may have been incorrectly packaged with a V-neck flange instead of a straight flange.
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 (April 15, 2026), Freudenberg Medical Blom-Singer Voice Prosthesis Recall (June 17, 2026) and Blom-Singer Classic Voice Prosthesis Recall (June 17, 2026).
How to tell if you have this one
Check for the model number REF 60PFSS45 and lot number 3991195 on the tube packaging. The affected units were sold by Smiths Medical.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tube Packaging
Look for the model number REF 60PFSS45 and lot number 3991195 on the tube packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years 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-0726-2021 (December 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0726-2021 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.