The Recall Desk
SevereFDA (Devices)·Z-1877-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Risk, FDA Class I Recall

Teleflex LLC is recalling approximately 15,810 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The affected 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 is an FDA Class I recall, which under the recall rubric mandates a minimum severity score of 4 (Severe). The potential for airway disconnection during critical medical procedures presents a serious hazard, though no deaths or injuries are described in the available source text.

Plain-English summary

Teleflex LLC is recalling Preformed AGT Oral Endotracheal Tubes (REF 111780075) following reports that the 15mm connector can disconnect from the tube. Endotracheal tubes are critical airway management devices used in operating rooms, intensive care units, and emergency departments.

The recall affects approximately 15,810 units that were distributed nationwide, including Puerto Rico. Specific batch and serial numbers are identified in the FDA recall notice.

Healthcare facilities and individuals using these tubes should stop using the affected batch numbers immediately and contact Teleflex LLC for replacement units or instructions. If a patient received care with one of these tubes and has concerns about potential disconnection, they should consult with their healthcare provider.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780075
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway
Hazard
Affected units
15,810

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 14026704341112
  • Batch Numbers: 18FG21
  • 18FG31
  • 18GG19
  • 18HG23
  • 18HG30
  • 18IG16
  • 18IG30
  • 18JG35
  • 18KG19
  • 18KG41
  • 18LG18
  • 19AG03
  • 19BG04
  • 19BG19
  • 19CG03
  • 19CT36
  • 19DT34
  • 19FT37
  • 19GT65

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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