The Recall Desk
SevereFDA (Devices)·Z-1963-2023·Announced 2023-07-05

Endotracheal Tubes Recalled Due to 15mm Connector Disconnection Risk

TELEFLEX endotracheal tubes are being recalled due to potential disconnection of the 15mm connector from the breathing tube. The disconnection could compromise respiratory support in patients.

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 classified as FDA Class I by the FDA, which mandates a minimum severity score of 4. No deaths or serious injuries are reported in the source material.

Plain-English summary

TELEFLEX LLC is recalling 3,843 units of Endotracheal Tube oral/nasal Magill endotracheal tubes with High Volume, Low Pressure cuffs (UDI/DI 14026704341266). The recall includes multiple batch numbers manufactured between 2018 and 2022.

The FDA has classified this as a Class I recall due to reports of the 15mm connector disconnecting from the endotracheal tube. A disconnected connector could prevent proper ventilation support and pose a serious risk to patients requiring respiratory assistance.

The affected tubes were distributed nationwide, including Puerto Rico. Affected batch numbers include: 18FG02, 18GG15, 18IG13, 18IG22, 18JG17, 18JG38, 19BG21, 19DT19, 19GT24, 19HT26, 19JT20, 19KT19, 19KT38, 19KT50, 19LT46, 19LT47, 20AT06, 20BT09, 20DT23, 20GG39, KME21G0866, KME22A2268, KME22B0062.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080080
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory
Hazard
Affected units
3,843

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: 18FG02
  • 18GG15
  • 18IG13
  • 18IG22
  • 18JG17
  • 18JG38
  • 19BG21
  • 19DT19
  • 19GT24
  • 19HT26
  • 19JT20
  • 19KT19
  • 19KT38
  • 19KT50
  • 19LT46
  • 19LT47
  • 20AT06
  • 20BT09
  • 20DT23

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 →

Related recalls

Same manufacturer · TELEFLEX LLC

See all →

Same hazard · connector disconnection

See all →