The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1875-2023·Announced 2023-07-05

Endotracheal Tubes Recalled for 15mm Connector Disconnection

TELEFLEX is recalling approximately 25,435 endotracheal tubes (REF 100382035) distributed nationwide due to reported disconnection of the 15mm connector from the device.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 is the most serious classification for medical devices. Although the source does not report deaths, injuries, or hospitalizations, the Class I designation reflects significant health hazards associated with the 15mm connector disconnection defect in a critical airway management device.

Plain-English summary

TELEFLEX LLC is recalling endotracheal tubes with an oral/nasal uncuffed/plain Murphy design (REF 100382035). Approximately 25,435 units of this device were distributed to healthcare facilities nationwide, including Puerto Rico.

The recall was prompted by reports of disconnection of the 15mm connector from the endotracheal tube during use. This connector is the interface point between the tube and other airway management components.

The affected batch numbers and lot identifiers are specified in the official FDA recall notice. Healthcare facilities that received these products should verify whether any affected units remain in their inventory.

Further information and guidance regarding the recalled devices is available from TELEFLEX LLC and the U.S. Food and Drug Administration.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Equipment
Hazard
Affected units
25,435

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 14026704340801
  • Batch Numbers: 18GG15
  • 18GT32
  • 18IG13
  • 18KG24
  • 18KG33
  • 18KG34
  • 18LG01
  • 18LG03
  • 19CG05
  • 19CT36
  • 19CT72
  • 19DT13
  • 19KT20
  • 20AT05
  • 20AT50
  • 20BG19
  • 20BT43
  • 20DT01
  • 20DT04

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 →

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