The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1882-2023·Announced 2023-07-05

TELEFLEX Endotracheal Tubes Recalled Due to Connector Disconnection Risk

TELEFLEX is recalling 760 endotracheal tubes due to reports of 15mm connector disconnection. This medical device failure could compromise airway management during critical care.

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 recall is classified as FDA Class I, which meets the Critical severity criterion per the rubric. The 15mm connector disconnection in a life-support device like an endotracheal tube represents a serious airway-management hazard with potential for critical patient harm during intubation.

Plain-English summary

TELEFLEX LLC is recalling 760 endotracheal tubes (model Magill, High Volume, Low Pressure Cuff, REF 112080095) distributed nationwide, including Puerto Rico. The recalled product is identified by UDI/DI 14026704341266 and includes the following batch numbers: 18IT25, 18JG13, 19CT66, 19HT79, 19KT08, 20BT13, 20DT19, and KME22C0673.

The recall was initiated due to reports that the 15mm connector may disconnect from the endotracheal tube. A disconnected connector during use could result in loss of airway access, which is a critical safety concern for patients requiring intubation and mechanical ventilation.

Healthcare facilities and medical professionals using these specific batch numbers should immediately identify and quarantine affected products. Contact TELEFLEX for information about returning affected units and obtaining replacement products.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
760

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 (9)

  • UDI/DI 14026704341266
  • Batch Numbers: 18IT25
  • 18JG13
  • 19CT66
  • 19HT79
  • 19KT08
  • 20BT13
  • 20DT19
  • KME22C0673

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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