The Recall Desk
SevereFDA (Devices)·Z-1926-2023·Announced 2023-07-05

TELEFLEX Endotracheal Tubes Recalled for 15mm Connector Disconnection

TELEFLEX is recalling 5,990 endotracheal tubes due to reports of 15mm connector disconnection. 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: FDA Class I medical device recall. Class I indicates a reasonable probability that the defect will cause serious injury or death. No illnesses or injuries have been reported; however, the Class I designation establishes a minimum severity score of 4 per the rubric.

Plain-English summary

TELEFLEX LLC is recalling 5,990 Magill endotracheal tubes (ET tubes) due to reports of the 15mm connector disconnecting from the device. The endotracheal tube is a respiratory device used to maintain an open airway during anesthesia or mechanical ventilation. If the connector disconnects during use, it could compromise the patient's airway.

The affected product is Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030 (UDI/DI 14026704340627). Affected batch numbers are 19ET31, 19FT28, 19GT08, 19GT31, 19GT35, 19GT48, 19HT05, 19HT32, 19HT60, 19IT38, 20DT09, 20DT24, 20ET03, 20FT55, and 20GT37. The recall affects units distributed nationwide, including Puerto Rico.

If you have this product, do not use it and contact TELEFLEX LLC.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380030
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Endotracheal Tube
Hazard
Affected units
5,990

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 (16)

  • UDI/DI 14026704340627
  • Batch Numbers: 19ET31
  • 19FT28
  • 19GT08
  • 19GT31
  • 19GT35
  • 19GT48
  • 19HT05
  • 19HT32
  • 19HT60
  • 19IT38
  • 20DT09
  • 20DT24
  • 20ET03
  • 20FT55
  • 20GT37

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 →