The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1933-2023·Announced 2023-07-05

Teleflex Endotracheal Tubes Recalled for 15mm Connector Disconnection

Teleflex is recalling 190 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. This disconnection could compromise airway management and ventilation.

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 requires a minimum severity rating of 4 per the rubric rules. No illnesses, injuries, or deaths are reported in the source text. The hazard—connector disconnection in a critical airway management device—poses serious potential risk without documented adverse outcomes.

Plain-English summary

Teleflex LLC is recalling endotracheal tubes (REF 100380065) nationwide, including Puerto Rico. The recall affects 190 units across batch numbers 19GT16, 19KT41, and KME21D0517.

Reports indicate that the 15mm connector on the affected tubes may disconnect from the endotracheal tube. The disconnection of this connector from airway management equipment poses a potential serious risk.

The endotracheal tubes are uncuffed/plain oral-nasal tubes in the Magill design. They were distributed with UDI/DI 14026704340696.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
190

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 (4)

  • UDI/DI 14026704340696
  • Batch Numbers: 19GT16
  • 19KT41
  • KME21D0517

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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