The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1948-2023·Announced 2023-07-05

Endotracheal Tube Recalled for 15mm Connector Disconnection Risk

TELEFLEX LLC is recalling 9,070 Preformed AGT Oral Endotracheal Tubes nationwide due to reports of 15mm connector disconnection. This medical device is used for airway management in hospital settings.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall (the most serious FDA classification), which establishes a minimum severity of 4 per the rubric. No illnesses, injuries, or deaths have been reported in the source text.

Plain-English summary

TELEFLEX LLC is recalling 9,070 units of Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff (REF 111780080) distributed nationwide, including Puerto Rico. The affected product is identified by UDI/DI 14026704341129 and includes specific lot and batch numbers documented by the FDA.

The recall is due to reports of disconnection of the 15mm connector from the endotracheal tube. An endotracheal tube is a medical device used for airway management and ventilation support in hospital and clinical settings. Connector disconnection could impair the device's function during critical patient use.

Healthcare facilities and providers should immediately verify their inventory against the affected lot numbers. Stop using the affected units and follow TELEFLEX LLC and FDA guidance for return or replacement instructions. Consult with your healthcare provider if you believe you have been exposed to a recalled device and have concerns about your care.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway Equipment
Hazard
Affected units
9,070

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 14026704341129
  • Batch Numbers: 18FG33
  • 18GG23
  • 18GG34
  • 18HG30
  • 18IG11
  • 18IG18
  • 18JG21
  • 18JG35
  • 18KG19
  • 18KG41
  • 19AG15
  • 19BG04
  • 19BG19
  • 19GT65
  • 19HT68
  • 19IT15
  • 19LT21
  • 20AT26
  • 20CT12

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 →

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