The Recall Desk
SevereFDA (Devices)·Z-1885-2023·Announced 2023-07-05

Teleflex endotracheal tubes recalled due to connector disconnection

Teleflex has recalled 49,050 endotracheal tubes due to reported disconnection of the 15mm connector. Affected units were 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: This is a FDA Class I recall, the most serious regulatory classification. Per the rubric, FDA Class I recalls warrant a minimum severity score of 4. No deaths or serious injuries are reported in the source material, so the score does not reach 5 (Critical). The Class I designation reflects the FDA's assessment of significant risk.

Plain-English summary

Teleflex LLC is recalling 49,050 endotracheal tubes (Oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, model REF 112082055). The FDA has classified this as a Class I recall due to reports of disconnection of the 15mm connector from the device.

An endotracheal tube is a breathing tube used by medical professionals during surgery, intubation, and mechanical ventilation. The 15mm connector is the part that attaches the tube to breathing equipment. Reports indicate that this connector may separate from the tube.

The recalled devices were distributed nationwide throughout the United States, including Puerto Rico. The FDA has identified specific batch numbers associated with this issue.

Patients and healthcare facilities should contact their medical provider if they have concerns about whether the affected product was used. Facilities should check batch numbers and discontinue use of any matching units.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082055
Manufacturer
TELEFLEX LLC
Hazard
  • connector-disconnection
  • airway-compromise

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 14026704341396
  • Batch Numbers: 18FG33
  • 18FT26
  • 18GG13
  • 18GG15
  • 18GG25
  • 18GT11
  • 18GT34
  • 18HG28
  • 18IG05
  • 18IG14
  • 18JT04
  • 18KG25
  • 18KG26
  • 18LG19
  • 18LG40
  • 19AG19
  • 19AG32
  • 19AG33
  • 19ET31

Distribution

Distributed nationwide across the United States.