Use cautionMedical device recall · FDA · Published May 26, 2020
Smiths Medical Pediatric Tracheostomy Tube Recall: Wrong Size Risk
Smiths Medical recalls pediatric tracheostomy tubes with incorrect neck flange size. This may cause breathing issues if used improperly. Affected units include model 60HA30, lot 37941: 3.5mm ID plate instead of 3.0mm.
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate.
Take action
Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
“Smiths Medical Pediatric Tracheostomy Tube Recall: Wrong Size Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65096-smiths-medical-pediatric-tracheostomy-tube-recall-wrong-size-risk. Based on FDA recall #Z-2485-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2485-2020%22&limit=1).
Smiths Medical ASD Inc. recalled Pediatric Adjustable Flange Tracheostomy Tube Cuffless devices due to packaging errors, according to the FDA on May 26, 2020. The agency announced the voluntary Class II recall of 20 units distributed in the U.S. and internationally.
One lot of 3.0mm Bivona Cuffless Adjustable Neck Flange Hyperflex Pediatric Tracheostomy Tubes was packaged with a 3.5mm ID adjustable neck flange plate, according to the FDA.
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 Medline Intubation Tray Recall (Dec. 24, 2025), Medline 14 Fr Suction Catheter Kits Recall (Dec. 24, 2025) and Covidien Shiley Tracheostomy Tube Recall (April 15, 2026).
How to tell if you have this one
Check for model number 60HA30 and lot number 3794165 on the tube packaging. The affected tubes have a 3.5mm ID adjustable neck flange plate instead of the 3.0mm size.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Tube Size
Verify the neck flange plate size on the tube; it should be 3.0mm, not 3.5mm.
Where it went and when
Where it was distributed
Distributed in 4 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “U.S: NE, TN, TX, and MS. Worldwide: France, Sweden, United Arab Emirates, UK, Netherlands, Czechia, Australia and Denmark.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Mississippi, Nebraska, Tennessee, Texas.
Recall timeline
FDA terminated this recall 11 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-2485-2020 (May 26, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2485-2020 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.