The Recall Desk
SevereFDA (Devices)·Z-1866-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Recall for Teleflex Preformed AGT Tubes

Teleflex is recalling 3,309 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. This defect may compromise airway management during medical use.

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 an FDA Class I recall, which mandates a minimum severity score of 4 per the rubric. Although the source does not report injuries or deaths, the potential for serious harm from connector disconnection during critical airway management procedures is significant.

Plain-English summary

Teleflex LLC is recalling 3,309 units of the Preformed AGT Oral Endotracheal Tube (uncuffed/plain, Murphy type, REF 100180055) due to reports of the 15mm connector disconnecting from the tube.

Endotracheal tubes are critical airway management devices used in clinical settings. Disconnection of the connector during use could prevent proper airway management and ventilation.

The recalled units were distributed nationwide in the United States, including Puerto Rico. Affected batch numbers include 18IG24, 18JG36, 18LG33, 19AG11, 19AG21, 19DT06, 19ET58, 19FT22, 19FT49, 19HT04, 19HT34, 19HT80, 19IT43, 19JT02, 20AT49, 20BT53, 20CT24, 20DT24, 20GG27, KME20K2673, KME20M0950, KME21A0310, KME21B0602, and KME22F0738.

Healthcare facilities that received affected units should immediately quarantine and remove them from service and contact Teleflex for instructions on product return and replacement.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180055
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management / Endotracheal Tube
Hazard
Affected units
3,309

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 14026704340481
  • Batch Numbers: 18IG24
  • 18JG36
  • 18LG33
  • 19AG11
  • 19AG21
  • 19DT06
  • 19ET58
  • 19FT22
  • 19FT49
  • 19HT04
  • 19HT34
  • 19HT80
  • 19IT43
  • 19JT02
  • 20AT49
  • 20BT53
  • 20CT24
  • 20DT24
  • 20GG27

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

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Same hazard · connector disconnection

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