The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1957-2023·Announced 2023-07-05

Preformed AGT Oral Endotracheal Tubes Recalled for Connector Disconnection

TELEFLEX is recalling approximately 8,620 Preformed AGT Oral Endotracheal Tubes distributed nationwide due to reports of disconnection of the 15mm connector from the tube.

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: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls never score below 4. The connector disconnection hazard represents a serious potential defect in a critical airway management device.

Plain-English summary

TELEFLEX LLC is recalling approximately 8,620 units of Preformed AGT Oral Endotracheal Tubes (REF 111781080) that were distributed nationwide, including Puerto Rico.

The recall is due to reports of disconnection of the 15mm connector from the endotracheal tube. The product's UDI is 14026704341242, and multiple batch numbers are affected in this recall.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781080
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management Device
Hazard
Affected units
8,620

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 14026704341242
  • Batch Numbers: 18GG18
  • 18HG21
  • 18IG16
  • 18KG01
  • 18KG19
  • 18LG18
  • 19BG18
  • 19BG33
  • 19GT13
  • 19HT31
  • 19HT55
  • 19IT15
  • 19JT35
  • 19KT14
  • 19LT21
  • 20AT26
  • 20CT11
  • 20FT68
  • 20GT49

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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