The Recall Desk
CriticalFDA (Devices)·Z-1947-2023·Announced 2023-07-05

Preformed AGT Endotracheal Tubes Recalled Due to Connector Disconnection

Teleflex is recalling 25,520 Preformed AGT endotracheal tubes due to reports of 15mm connector disconnection. This is an FDA Class I recall affecting units distributed nationwide.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls are classified as Critical (score 5).

Plain-English summary

Teleflex LLC is recalling 25,520 units of Preformed AGT Oral Endotracheal Tubes (REF 111780070) with Murphy Eye, High Volume, Low Pressure Cuff. The recalled products were distributed nationwide in the United States and Puerto Rico.

The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube. The affected batch numbers are listed in the FDA recall notice (UDI/DI: 14026704341105).

Healthcare providers who may have received these tubes should verify batch numbers against the FDA recall notice. Quarantine any units that match the affected batch numbers. Contact Teleflex LLC for replacement or further guidance. Report any incidents to the FDA MedWatch program.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780070
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management Equipment
Hazard
Affected units
25,520

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 14026704341105
  • Batch Numbers: 18FG12
  • 18FG24
  • 18GG01
  • 18GG26
  • 18GT26
  • 18HG36
  • 18IG14
  • 18IT05
  • 18JG07
  • 18KG10
  • 18KG34
  • 18LG11
  • 18LG31
  • 19AG36
  • 19CG07
  • 19CT69
  • 19ET12
  • 19GT39
  • 19GT44

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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