Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bioseal Trachea Extender 1/pl 50pk/Cs Recalled by Bioseal Corporation Due to The reported stress crack in the port of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bioseal Corporation directly.
Affected Products
Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX, Expiration Date XXXX, LF, UDI: (01) 00630094916019 - Product Usage: Airway connectors intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or mask.
Quantity: 900 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Bioseal Corporation
Bioseal Corporation has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report