Teleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment
Teleflex is recalling specific lots of Bronchial Double Lumen Tube Sets because the cobb connector may detach from the main connector before use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a medical device component prior to use, which poses a risk of harm but has no reported injuries or illnesses in the source text.
Plain-English summary
Teleflex, Inc. is recalling the Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile. The recall is due to customer complaints that the cobb connector detached from the main connector prior to use.
The affected product is identified by Product Code 116164-000390 and Batch Number 14BT21. The recall is classified as Class II by the U.S. Food and Drug Administration.
The product was distributed to facilities in numerous U.S. states, Washington D.C., Puerto Rico, and several international locations including Canada, Bolivia, Ecuador, Hong Kong, Malaysia, the Philippines, Taiwan, and Trinidad & Tobago. Healthcare facilities should stop using the affected units and contact Teleflex for instructions on return or replacement.
The recalled product
- Product
- Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile
- Manufacturer
- Teleflex, Inc.
- Category
- Medical Device — Respiratory
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product Code 116164-000390 Batch Number 14BT21
Distribution
Part of a larger recall action
This product is one of 9 recalled by Teleflex, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
Same manufacturer · Teleflex, Inc.
See all →- HighTeleflex Recalls Tracheopart Sets Due to Connector Detachment
FDA (Devices) · 2015-08-26
- HighTeleflex Recalls Bronchial One Lumen Tubes Due to Connector Detachment
FDA (Devices) · 2015-08-26
- HighTeleflex Recalls Tracheopart Sets Due to Connector Detachment
FDA (Devices) · 2015-08-26
- ModerateTeleflex Recalls Bronchial Double Lumen Tube Sets Due to Connector Detachment
FDA (Devices) · 2015-08-26
- HighTeleflex Recalls Bronchial One Lumen Tubes Due to Connector Detachment
FDA (Devices) · 2015-08-26
Same hazard · mechanical failure
See all →- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28