The Recall Desk
SevereFDA (Devices)·Z-1880-2023·Announced 2023-07-05

Endotracheal Tubes Recalled Due to Connector Disconnection Risk

Teleflex LLC is recalling 17,840 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. These tubes have been 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 FDA Class I device recall meets the threshold for Severe classification. Per the rubric, FDA Class I recalls never fall below a score of 4. The connector disconnection in an endotracheal tube poses a serious hazard during patient care, though no injuries or illnesses have been reported.

Plain-English summary

Teleflex LLC is recalling approximately 17,840 Preformed AGT Oral Endotracheal Tubes, Model REF 111781075, with Murphy Eye, High Volume, Low Pressure Cuff. These are medical devices used for airway management in intubated patients.

The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube. The FDA has classified this as a Class I recall, which designates it as a defect or noncompliance that poses a serious hazard to health.

The affected tubes were distributed nationwide, including Puerto Rico. Approximately 17,840 units are affected across multiple batch numbers from 2018 through 2023. The UDI/DI for these products is 14026704341235.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781075
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
17,840

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 14026704341235
  • Batch Numbers: 18FG21
  • 18GG18
  • 18GG19
  • 18HG29
  • 18IG17
  • 18JG03
  • 18JG20
  • 18JG35
  • 18KG01
  • 18KG43
  • 18LG18
  • 19AG25
  • 19BG03
  • 19BG18
  • 19BG20
  • 19DT38
  • 19ET36
  • 19FT02
  • 19HT55

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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