The Recall Desk
SevereFDA (Devices)·Z-1849-2023·Announced 2023-07-05

Flexi-Set Endotracheal Tubes recalled for connector disconnection

Teleflex is recalling over 1 million Flexi-Set Cuffed Endotracheal Tube kits due to reports of 15mm connector disconnection from the tube. The recall affects products distributed nationwide.

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: The FDA classified this as a Class I recall, which requires a minimum severity score of 4. Disconnection of the 15mm connector on an endotracheal tube affects a critical medical device with direct patient contact during airway procedures.

Plain-English summary

Teleflex LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (REF 504570) due to reports of disconnection of the 15mm connector from the endotracheal tube. The endotracheal tube is a medical device used for oral and nasal intubation in clinical settings.

The recall affects approximately 1,051,810 units distributed nationwide, including Puerto Rico. The affected batch numbers span from 2018 through 2022 and are identified by UDI/DI 4026704547616 along with additional KME batch codes.

Healthcare facilities and patients should verify whether their supplies match any of the recalled batch numbers and contact the manufacturer for guidance on replacement or corrective action.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504570
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
1,051,810

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 4026704547616
  • Batch Numbers: 18FG03
  • 18FG13
  • 18FG21
  • 18FG22
  • 18FG30
  • 18FT32
  • 18GG02
  • 18GG08
  • 18GG20
  • 18GT32
  • 18HG07
  • 18HG16
  • 18HG19
  • 18HG32
  • 18HG35
  • 18HG38
  • 18IG02
  • 18IG06
  • 18IG12

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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