The Recall Desk
SevereFDA (Devices)·Z-1953-2023·Announced 2023-07-05

Endotracheal Tubes Recalled for Potential 15mm Connector Disconnection

TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tubes because the 15mm connector may disconnect from the tube, creating a potential airway access risk.

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 involves disconnection of a critical airway connector in endotracheal tubes used in life-support scenarios. No illnesses or injuries are reported in the source text.

Plain-English summary

TELEFLEX LLC has issued a Class I FDA recall of Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055, affecting 172,721 units distributed nationwide, including Puerto Rico.

The recalled tubes have been reported to experience disconnection of the 15mm connector from the endotracheal tube. Endotracheal tubes are critical medical devices used to maintain airway access in patients undergoing anesthesia, in intensive care, and in emergency settings.

Healthcare facilities should identify affected units using the batch numbers and UDI/DI information provided in FDA recall notice Z-1953-2023 and contact TELEFLEX LLC for guidance on device management and replacement.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781055
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
172,721

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 14026704341198
  • Batch Numbers: 18FT35
  • 18FT39
  • 18GG17
  • 18GG18
  • 18GT32
  • 18IG10
  • 18IG16
  • 18IG17
  • 18JG13
  • 18JG20
  • 18JG35
  • 18JG37
  • 18KG18
  • 18KG39
  • 18KG41
  • 18LG12
  • 18LG14
  • 18LG30
  • 18LG39

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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