The Recall Desk
SevereFDA (Devices)·Z-1961-2023·Announced 2023-07-05

TELEFLEX Endotracheal Tubes Recalled for Connector Disconnection Risk

TELEFLEX is recalling 17,950 endotracheal tubes due to reports of the 15mm connector disconnecting from the device. These are critical airway support devices.

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 minimum score of 4 per the rubric. Source reports actual connector disconnections with no reported deaths or injuries, so score remains 4 (Severe) rather than 5 (Critical).

Plain-English summary

TELEFLEX LLC is recalling 17,950 units of the Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff (REF 112080070). The affected product was distributed nationwide, including Puerto Rico, and is identified by UDI/DI 14026704341266.

Reports indicate the 15mm connector is disconnecting from the endotracheal tube in affected units. Endotracheal tubes are medical devices used to establish and maintain airway access in patients undergoing anesthesia or requiring respiratory support.

Multiple batch numbers are affected by this Class I recall. Healthcare facilities should verify their inventory against the affected batch numbers listed in the recall notice.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection

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 14026704341266
  • Batch Numbers: 18FG19
  • 18GG19
  • 18HG28
  • 18IG06
  • 18IG19
  • 18JG13
  • 18JG17
  • 18KG13
  • 18LT07
  • 19BG19
  • 19CT26
  • 19DT20
  • 19ET12
  • 19ET36
  • 19HT26
  • 19HT69
  • 19JT21
  • 19KT14
  • 19LT31

Distribution

Distributed nationwide across the United States.