The Recall Desk
SevereFDA (Devices)·Z-1847-2023·Announced 2023-07-05

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
Category
Medical Device — Airway Management Device
Hazard
Affected units
103,842

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.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 123 recalled by TELEFLEX LLC 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 123 products in this recall →

Related recalls

Same manufacturer · TELEFLEX LLC

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Same hazard · connector disconnection

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