Flexi-Set Endotracheal Tubes recalled for connector disconnection risk
TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets nationwide due to reports of connector disconnection. The affected devices may disconnect during use, potentially compromising airway management.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4. The hazard—connector disconnection from a critical airway management device—has been reported to occur. No deaths or hospitalizations are explicitly stated in the source.
Plain-English summary
TELEFLEX LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504560) nationwide, including Puerto Rico. This medical device is used for airway management and intubation. The recall affects 103,842 units distributed in the United States.
The U.S. Food and Drug Administration (FDA) has classified this recall as a Class I issue based on reports that the 15mm connector may disconnect from the endotracheal tube during use. A disconnection could result in loss of the airway during patient care.
Healthcare facilities, hospitals, emergency departments, and other medical settings that use this product are affected. The recalled product includes multiple batch numbers and UDI code 4026704547593.
Healthcare providers should immediately cease use of affected batches and contact TELEFLEX LLC. Facilities should check their inventory against the recalled batch numbers provided in this notice. Patients who have received treatment with this device should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504560
- Manufacturer
- TELEFLEX LLC
- Hazard
- connector-disconnection
- airway-loss
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)
- UDI/DI 4026704547593
- Batch Numbers: 18FG03
- 18FG15
- 18FG28
- 18GG24
- 18IG27
- 18JG02
- 18JG17
- 18JG26
- 18JG34
- 18KG09
- 18KG35
- 18LG05
- 18LG12
- 18LG18
- 18LG37
- 19AG27
- 19AG37
- 19BG12
- 19CT32
Distribution
Distributed nationwide across the United States.
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