The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1942-2023·Announced 2023-07-05

Teleflex endotracheal tubes recalled for connector disconnection risk

Teleflex is recalling Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. This Class I recall affects 23,395 units distributed nationwide.

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: The FDA Class I classification for this endotracheal tube connector defect requires a minimum severity of Severe. The mechanical failure of a critical airway management device connector presents a serious patient safety risk, though no deaths or serious injuries have been reported in the source documentation.

Plain-English summary

Teleflex LLC is recalling Preformed AGT Oral Endotracheal Tubes (Model REF 111780045, UDI 14026704341051) due to reports of disconnection of the 15mm connector from the tube. The affected tubes feature a Murphy eye, high-volume, low-pressure cuff design.

Disconnection of the 15mm connector could prevent the endotracheal tube from functioning properly. These tubes are used to maintain an open airway and deliver oxygen during anesthesia and mechanical ventilation. If the connector disconnects during use, it could compromise the patient's ability to breathe and receive oxygen.

The recall affects 23,395 units distributed nationwide, including Puerto Rico. Affected units can be identified by batch numbers and the UDI/DI code 14026704341051 as listed in the official FDA recall notice.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780045
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management / Endotracheal Tube
Hazard
Affected units
23,395

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 14026704341051
  • Batch Numbers: 18FG12
  • 18GG26
  • 18GT26
  • 18HG24
  • 18HG36
  • 18JG13
  • 18JG36
  • 18LG31
  • 18LG33
  • 19AG11
  • 19AG21
  • 19CG07
  • 19DT42
  • 19FT18
  • 19GT43
  • 19JT02
  • 19KT37
  • 19LT32
  • 20AT13

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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