Use caution Medical device recall · FDA · Published January 18, 2021

Smiths Medical FlexTend Tracheostomy Tube Recall: Incorrect Flange Risk

Smiths Medical recalls specific model 60PFS45 tracheostomy tubes with incorrect straight neck flange that may cause tissue injury if used improperly.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1145-2021Medical device Smiths Medical ›

Use caution until it’s fixed

Smiths Medical became aware that three lot numbers of a specific model of Bivona¿ Cuffless FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. As a result, there is potential for patient injury if an incorrect device or accessory is selected for use. This use could lead to an internal injury resulting from excessive device contact with tissue, or an external patient injury due to external portions of the device pressing into or rubbing against tissue.

Take action

Contact the company

Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690

✎ GovInfoNow plain-language explainer

Smiths Medical is recalling certain tracheostomy tubes that may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. This could cause tissue injury if the wrong tube is used during medical procedures. Read more at govinfonow.com/recall/63371-smiths-medical-flextend-tracheostomy-tube-recall-incorrect-flange-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/63371-smiths-medical-flextend-tracheostomy-tube-recall-incorrect-flange-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1145-2021

Cite this page

“Smiths Medical FlexTend Tracheostomy Tube Recall: Incorrect Flange Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63371-smiths-medical-flextend-tracheostomy-tube-recall-incorrect-flange-risk. Based on FDA recall #Z-1145-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2021%22&limit=1).

The FDA announced on Jan. 18, 2021, that Smiths Medical ASD Inc. is recalling specific Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tubes due to potential patient injury from incorrect packaging. The agency stated the recall is voluntary and involves units distributed nationwide.

How to tell if you have it

Brand: Smiths Medical
Product: Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube (model 60PFS45)
Lot codes: 3991171, 3991172, and 3988103

The hazard

The FDA said the affected tubes may have been incorrectly packaged with a straight neck flange instead of a V-neck flange. This error creates potential for patient injury if an incorrect device is selected, which could lead to internal injury from excessive tissue contact or external injury from the device pressing into skin.

Context

GovInfoNow's records show Smiths Medical ASD, Inc. has issued 73 other recalls since June 5, 2017. Recent Smiths Medical recalls include the April 10, 2025 CADD Solis VIP Infusion Pump recall for potential thermal damage and false alarm risks, as well as a separate April 10, 2025 recall for wireless connection alarms in the CADD Solis HSPCA Pump. Other recent recalls of similar products include the Covidien Shiley Tracheostomy Tube Recall (April 15, 2026) and Medtronic Octopus Nuvo Tissue Stabilizer Recall (Jan. 13, 2026).

How to tell if you have this one

Check for the model number 60PFS45 and lot numbers 3991171, 3991172, or 3988103 on the tube packaging. These specific lots were recalled due to potential packaging errors.

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 60PFS45 and lot numbers 3991171, 3991172, or 3988103 on the tube packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 26 states.

FDA distribution: “US Nationwide distribution including in the states of AL, AZ, CA, CT, FL, GA, IA, IL, KS, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TX, UT, VA, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Connecticut, Florida, Georgia, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Massachusetts, Michigan, Minnesota, Missouri, New Jersey, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Utah, Virginia, Washington.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

Jan 18, 2021Firm started the recall
Feb 23, 2021FDA classified it Class II
Mar 3, 2021Published in FDA’s Enforcement Report
Dec 20, 2022FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/63371-smiths-medical-flextend-tracheostomy-tube-recall-incorrect-flange-risk">Smiths Medical FlexTend Tracheostomy Tube Recall: Incorrect Flange Risk (GovInfoNow)</a>

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-1145-2021 (January 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1145-2021 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.