The Recall Desk
SevereFDA (Devices)·Z-1891-2023·Announced 2023-07-05

Teleflex Endotracheal Tubes Recalled for 15mm Connector Disconnection

Teleflex is recalling approximately 39,550 endotracheal tubes due to reports of 15mm connector disconnection. The FDA Class I recall affects units distributed nationwide including Puerto Rico.

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: Per the severity rubric, FDA Class I recalls require a minimum score of 4. Although the source text does not report illnesses or deaths, only connector disconnection incidents, the Class I designation indicates the FDA determined this hazard poses a serious patient safety risk.

Plain-English summary

Teleflex LLC is recalling 39,550 units of Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff (REF 112082085, UDI/DI 14026704341457) due to reported disconnection of the 15mm connector.

The affected devices were distributed nationwide throughout the United States and Puerto Rico. This is a Class I recall, the FDA's highest-priority classification for medical device recalls, indicating a serious patient safety hazard. Affected units are identified by UDI/DI 14026704341457, with batch numbers listed in the official FDA recall notice.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection
  • airway-loss

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 14026704341457
  • Batch Numbers: 18HG37
  • 18HT15
  • 18HT24
  • 18JG12
  • 18JG31
  • 19CT69
  • 19CT73
  • 19CT74
  • 19CT76
  • 19CT77
  • 19DT05
  • 19DT10
  • 19KT14
  • 19KT30
  • 19KT46
  • 19KT49
  • 19KT50
  • 19KT55
  • 19LT35

Distribution

Distributed nationwide across the United States.