The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1943-2023·Announced 2023-07-05

Oral Endotracheal Tubes Recalled for 15mm Connector Disconnection Risk

Teleflex LLC is recalling 19,842 preformed oral endotracheal tubes due to reports of 15mm connector disconnection. Affected devices were 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: FDA Class I classification establishes minimum severity of 4 per the rubric. The defect—connector disconnection in a critical airway device—poses significant risk of patient harm, though specific injuries or hospitalizations are not reported in the source.

Plain-English summary

Teleflex LLC is recalling 19,842 units of Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff (REF 111780050) due to reports of disconnection of the 15mm connector from the endotracheal tube.

The affected tubes were distributed nationwide, including Puerto Rico, under UDI/DI 14026704341068. Affected batch numbers are specified in the FDA recall notice.

Endotracheal tubes are critical medical devices used for airway management in hospitals and healthcare settings. A disconnected 15mm connector could compromise the tube's ability to maintain a secure airway. Healthcare providers should immediately cease use of affected units and contact Teleflex or the FDA for guidance on handling and replacement.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780050
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway
Hazard
Affected units
19,842

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 14026704341068
  • Batch Numbers: 18FG12
  • 18FG24
  • 18GG03
  • 18GT26
  • 18HG24
  • 18IG24
  • 18JG07
  • 18KG34
  • 18LG11
  • 18LG31
  • 19AG09
  • 19AG11
  • 19AG21
  • 19AG36
  • 19CG07
  • 19CT36
  • 19DT06
  • 19FT18
  • 19GT44

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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