Teleflex ISIS HVT Tracheal Tubes Recalled for Kinking Risk
Teleflex Medical is recalling ISIS HVT Tracheal Tubes because they can kink during use, potentially compromising the patient's airway.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "The tracheal tube can kink during patient use."
Plain-English summary
Teleflex Medical is recalling ISIS HVT Tracheal Tubes, Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, size 8.5. The recall involves 190,871 units distributed nationwide in the United States, Puerto Rico, and internationally to various countries including Canada, Mexico, and several nations in Europe, Asia, and South America.
The recall is being issued because the tracheal tubes can kink during patient use. A tracheal tube is a medical device inserted into a patient's trachea via the nose or mouth to maintain an open airway. Kinking of the tube could obstruct the airway, posing a risk to patient safety.
Healthcare providers and facilities should stop using the affected tracheal tubes immediately. Patients who have had these tubes inserted should contact their healthcare provider for evaluation and potential replacement. The affected product code is 5-14017, and the lot number is 01B1200215.
The recalled product
- Product
- ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Preloaded Stylet, 8.5, Rx only, Product Usage: A tracheal tube is a device inserted into a patients trachea via the nose or mouth and used to maintain an open airway.
- Manufacturer
- Teleflex Medical
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 (2)
- Product Code: 5-14017
- Lot numbers: 01B1200215.
Distribution
Part of a larger recall action
This product is one of 14 recalled by Teleflex Medical 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 14 products in this recall →Related recalls
Same manufacturer · Teleflex Medical
See all →- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- LowTeleflex RuSCH Male External Catheter Recalled for Incorrect Sterility Labeling
FDA (Devices) · 2020-01-22
- ModerateTeleflex Sheridan Endobronchial Tubes Recalled for Incorrect Labeling
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
- HighTeleflex Recalls Arrow EZ-IO Intraosseous Vascular Access System Needles
FDA (Devices) · 2019-12-25
Same hazard · airway obstruction
See all →- SevereGiven Imaging Recalls Bravo CF Capsule Delivery Devices Due to Attachment Failure
FDA (Devices) · 2026-09-16
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Failure
FDA (Devices) · 2026-09-02
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighMedline Recalls Neonatal Heated Wire Breathing Circuits Due to Thermal Damage
FDA (Devices) · 2026-09-02
- HighFORWARD Oral Airway Kit Recall for Potential Airway Obstruction
FDA (Devices) · 2026-08-12
Similar recalls
- CriticalTeleflex Recalls MAQUET SERVO Humidifiers Due to Cracked Flex Tubes
FDA (Devices) · 2015-02-18
- ModerateTeleflex Recalls RUSCH Endotracheal Tubes for Cuff Diameter Labeling Error
FDA (Devices) · 2015-02-25
- SevereTeleflex Medical Recalls Taut Intraducers Due to Gas Leakage Risk
FDA (Devices) · 2015-11-25
- HighTeleflex Recalls Sheridan Cuffed Tracheal Tubes Due to Labeling Inconsistency
FDA (Devices) · 2017-02-15
- ModerateTeleflex Recalls Sterile Tracheal Tubes Due to Size Labeling Error
FDA (Devices) · 2016-06-15
- HighTeleflex Medical Recalls Rusch Flexi-slip Tracheal Tube Stylets
FDA (Devices) · 2015-11-18