Lower riskMedical device recall · FDA · Published August 22, 2023
Smiths Medical Pediatric Tracheostomy Tube Recall: Incorrect Expiration Date Label
Smiths Medical recalls pediatric tracheostomy tubes with incorrect expiration date labeling on the box. The box shows 3/17/2021 but the tube itself expires 3/17/2026. This may cause confusion in medical use.
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).
Take action
Contact the company
📍Recalling firmSmiths Medical ASD Inc.6000 Nathan Ln N · Minneapolis, MN 55442-1690
“Smiths Medical Pediatric Tracheostomy Tube Recall: Incorrect Expiration Date Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57453-smiths-medical-pediatric-tracheostomy-tube-recall-incorrect-expiration-date-label. Based on FDA recall #Z-0205-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0205-2024%22&limit=1).
Smiths Medical ASD Inc. recalled Smiths Medical Portex Bivona Pediatric Tracheostomy Tubes due to incorrect expiration dates on unit boxes, according to the FDA. The Food and Drug Administration announced the Class II recall on August 22, 2023.
How to tell if you have it
Brand: Smiths Medical
Product: Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile
Lot #: 4125816
UDI-DI: 15021312005769
The hazard
The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) while the individual packaging contains the correct expiration date (3/17/2026).
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 Cook Medical Blue Rhino G2 Tracheostomy Tray Recall (March 5, 2026), Cook Medical Wayne Pneumothorax Tray Recall (March 5, 2026), and Covidien Shiley Tracheostomy Tube Recall (April 15, 2026).
How to tell if you have this one
Check for the model number 60P045 on the tube packaging. The box should show the expiration date as March 17, 2026, but the record indicates the box has an incorrect date of March 17, 2021.
Brand
Smiths Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Expiration Dates
Compare the expiration date on the box (should be March 17, 2026) with the tube's packaging (which shows March 17, 2026).
Where it went and when
Where it was distributed
Distributed in 18 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Hawaii, Illinois, Indiana, Massachusetts, Minnesota, Mississippi, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, South Carolina, Texas, Virginia, Washington.
Recall timeline
FDA published this recall 3 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
No, this is a labeling error that does not affect the tube's safety. The tube is still safe to use as long as the expiration date on the packaging is followed.
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-0205-2024 (August 22, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0205-2024 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.