The Recall Desk
SevereFDA (Devices)·Z-1850-2023·Announced 2023-07-05

Flexi-Set Endotracheal Tube Connectors Recalled Due to Disconnection Risk

TELEFLEX LLC is recalling Flexi-Set Cuffed Endotracheal Tube and Stylet Sets due to reports of 15mm connector disconnection. Approximately 684,042 units were distributed nationwide, including Puerto Rico.

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: This recall is classified FDA Class I by the U.S. Food and Drug Administration. Per the severity rubric, FDA Class I recalls cannot be scored below Severe (4).

Plain-English summary

TELEFLEX LLC is recalling the Flexi-Set Cuffed Endotracheal Tube and Stylet Set (model REF 504575) following reports of disconnection of the 15mm connector from the endotracheal tube. The product is used for oral and nasal intubation.

Approximately 684,042 units were distributed nationwide across the United States, including Puerto Rico. The recall affects multiple batch numbers.

The U.S. Food and Drug Administration has classified this as a Class I recall.

The recalled product

Product
Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504575
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway / Respiratory
Hazard
Affected units
684,042

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 4026704547623
  • Batch Numbers: 18FG05
  • 18FG13
  • 18FG30
  • 18GG02
  • 18GG08
  • 18GG12
  • 18GG17
  • 18GG20
  • 18GG28
  • 18HG01
  • 18HG12
  • 18HG22
  • 18HG27
  • 18HG35
  • 18HG38
  • 18IG09
  • 18IG17
  • 18IG27
  • 18IG30

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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