Teleflex Recalls Tracheopart Sets Due to Connector Detachment
Teleflex is recalling sterile Tracheopart Sets because the cobb connector may detach from the main connector before use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (connector detachment) in a medical device that could lead to injury, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teleflex, Inc. is recalling sterile Tracheopart Sets (Right) due to customer complaints that the cobb connector detached from the main connector prior to use. The recall covers specific product codes and batch numbers distributed across numerous U.S. states, Puerto Rico, and several international locations.
The affected products are identified by Product Codes 116401-000750, 116401-000850, and 116401-000950, along with specific batch numbers listed in the agency's structured data. The distribution pattern includes states such as Alabama, Alaska, Arizona, California, and others, as well as countries including Canada, Bolivia, and Ecuador.
Healthcare facilities and consumers should stop using these specific Tracheopart Sets and contact Teleflex, Inc. for instructions on return or replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Tracheopart Set (Right), Sterile
- Manufacturer
- Teleflex, Inc.
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 (20)
- Product Code 116401-000750 Batch Number 13FT06
- 13GT24
- 13JT21
- 13IT21R
- 13KT23
- 13KT23R
- 14CT21
- 14ET11
- 14ET22
- 14ET28
- 14FT16
- 14GT15
- 14GT23
- 14IT17
- 14JT18
- Product Code 116401-000850 Batch Number 13IT05
- 13KT05
- 13LT08
- 14CT16
- 14DT19
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 Carlens 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
- 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 →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- 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
Similar recalls
- SevereEndotracheal Tube Sets Recalled for Connector Disconnection Risk
FDA (Devices) · 2023-07-05
- HighTeleflex Recalls Infant Catheter Connectors Due to Sterility Concerns
FDA (Devices) · 2017-05-31
- SevereEndotracheal Tube Connector Disconnection Risk Prompts Teleflex Recall
FDA (Devices) · 2023-07-05
- SevereSlick Set endotracheal tubes recalled for connector disconnection
FDA (Devices) · 2023-07-05
- SevereTeleflex Slick Set Endotracheal Tube Connector Disconnection Recall
FDA (Devices) · 2023-07-05
- SevereFlexi-Set Endotracheal Tube Connector May Disconnect During Use
FDA (Devices) · 2023-07-05