Bioseal Corporation: Medical Device Recall in 2020 - (Recall #: Z-2795-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 15, 2019

Date Posted: August 19, 2020

Recall Number: Z-2795-2020

Event ID: 85288

Reason for Recall:

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.

Status: Terminated

Product Quantity: 900 units

Code Information:

Bioseal Part # TRAX01/50 Bioseal Lot #'s 400453, 400456, 400461, 400472, 400476

Distribution Pattern:

US Nationwide distribution including in the state of CA.

Voluntary or Mandated:

Voluntary: Firm initiated