The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1893-2023·Announced 2023-07-05

Teleflex Endotracheal Tubes Recalled Due to Connector Disconnection Risk

Teleflex is recalling 18,620 endotracheal tubes due to reported disconnection of 15mm connectors. The tubes are used for oral and nasal intubation and were distributed nationwide.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This is an FDA Class I medical device recall. FDA Class I classification indicates a serious defect with potential for critical patient harm, including loss of airway function during ventilation.

Plain-English summary

Teleflex LLC is recalling 18,620 endotracheal tubes (REF 112082095) designed for oral and nasal intubation. These single-use tubes feature Murphy eyes for improved visualization and use high-volume, low-pressure cuffs.

The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube. This connector attaches the tube to ventilation equipment. A disconnection could result in separation of the airway connection, preventing proper ventilation.

The affected products were distributed nationwide throughout the United States, including Puerto Rico. The recall is identified by UDI/DI code 14026704341471. Specific affected batches are identified by lot numbers including 18HG08, 18HT04, 18IG29, and additional batches listed by Teleflex.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082095
Manufacturer
TELEFLEX LLC
Category
Medical Device
Hazard
Affected units
18,620

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 14026704341471
  • Batch Numbers: 18HG08
  • 18HT04
  • 18IG29
  • 18IT04
  • 18JT16
  • 18KG37
  • 18KT27
  • 18LT16
  • 19BG02
  • 19CG02
  • 19CT04
  • 19CT72
  • 19GT25
  • 19HT19
  • 19HT47
  • 19JT05
  • 19KT55
  • 19LT08
  • 20AT13

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 →

Similar recalls