Stop using nowMedical device recall · FDA · Published August 15, 2019
Bioseal Trachea Extender Recall: Risk of Breathing System Leakage
Bioseal recalls trachea extenders with potential stress cracks causing breathing system leaks. Patients may not receive proper ventilation. Stop using immediately if you have the recalled model.
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient.
Take action
Contact the company
📍Recalling firmBioseal Corporation167 W Orangethorpe Ave · Placentia, CA 92870-6922
“Bioseal Trachea Extender Recall: Risk of Breathing System Leakage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67198-bioseal-trachea-extender-recall-risk-of-breathing-system-leakage. Based on FDA recall #Z-2795-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2795-2020%22&limit=1).
The FDA announced on August 15, 2019, that Bioseal Corporation voluntarily recalled Bioseal Trachea Extenders due to stress cracks in the swivel elbow port. These defects could cause leakage from the breathing system, preventing prescribed ventilation from reaching patients.
How to tell if you have it
Brand: Bioseal
Product: Bioseal Trachea Extender 1/pl 50pk/Cs
REF: TRAX01/50
UPC: 00630094916019
Lot codes: 400453, 400456, 400461, 400472, 400476
The hazard
The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system. This leakage could prevent prescribed ventilation from being delivered to the patient, posing a serious health risk if cracks reach a significant size.
Context
GovInfoNow's records show Bioseal Corporation has two other recalls on record since October 18, 2017. On March 23, 2021, Bioseal issued a recall for Central Line Dressing Kits due to the risk of Aspergillus growth in pre-op skin prep components. Other recent recalls of similar products include the Draeger ErgoStar CM 60 Airway Connector Recall (November 10, 2025), the Medline convenience kits with Olympus biopsy valves recall (February 16, 2026), and the Draeger ErgoStar CM 40 Airway Connector Recall (November 10, 2025).
How to tell if you have this one
Check for the product name 'Bioseal Trachea Extender 1/pl 50pk/Cs' with lot numbers 400453, 400456, 400461, 400472, or 400476. The product was manufactured with a specific date and expiration date.
Brand
Bioseal
Product
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using Immediately
If you have the recalled trachea extenders, stop using them right away to prevent breathing system leaks.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution including in the state of CA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 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-2795-2020 (August 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2795-2020 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.