The Recall Desk
SevereFDA (Devices)·Z-1883-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Risk Prompts FDA Class I Recall

TELEFLEX LLC is recalling 690 endotracheal tubes with high-volume, low-pressure cuff due to reports of connector disconnection. The affected products were distributed nationwide.

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 per the rubric. No reported deaths, serious injuries, or hospitalizations are documented in the source, so the score remains at 4 (Severe) rather than escalating to 5 (Critical).

Plain-English summary

TELEFLEX LLC is recalling 690 Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff units (REF 112080100) due to reports of disconnection of the 15mm connector from the endotracheal tube.

The affected products were distributed nationwide throughout the United States, including Puerto Rico. Batch numbers associated with this recall are: 18FT26, 18IT18, 18KG10, 19CG03, 19IT31, 20BT13, 20DT18, 20GT57, and KME22C0947.

The FDA has classified this as a Class I recall. Healthcare facilities and providers should identify whether they have inventory from the affected batch numbers.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080100
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway
Hazard
Affected units
690

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 (10)

  • UDI/DI 14026704341266
  • Batch Numbers: 18FT26
  • 18IT18
  • 18KG10
  • 19CG03
  • 19IT31
  • 20BT13
  • 20DT18
  • 20GT57
  • KME22C0947

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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