The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1956-2023·Announced 2023-07-05

Preformed AGT Oral Endotracheal Tubes Recalled for Connector Disconnection

Teleflex is recalling 35,513 preformed AGT oral endotracheal tubes nationwide due to reported connector disconnection from the 15mm tube connector.

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: FDA Class I recalls must score at least 4 per the rubric. No illnesses or deaths have been reported in the source material, therefore this scores 4 (Severe) rather than 5 (Critical).

Plain-English summary

Teleflex LLC is recalling 35,513 units of its Preformed AGT Oral Endotracheal Tube with Murphy Eye, High Volume, Low Pressure Cuff (REF 111781070) because the 15mm connector disconnects from the endotracheal tube.

The recalled tubes were distributed nationwide in the United States, including Puerto Rico. Affected batch numbers are detailed in the FDA recall notice.

Healthcare facilities and medical personnel should immediately discontinue use of affected units and contact Teleflex or their distributor for replacement instructions.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781070
Manufacturer
TELEFLEX LLC
Category
Medical Device — Endotracheal Tube
Hazard
Affected units
35,513

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 14026704341228
  • Batch Numbers: 18GG17
  • 18GG25
  • 18GT32
  • 18HG19
  • 18IG16
  • 18JG13
  • 18JG21
  • 18KG01
  • 18LG12
  • 18LG15
  • 18LG30
  • 19AG15
  • 19AG25
  • 19AG29
  • 19BG03
  • 19CT56
  • 19GT17
  • 19HT02
  • 19HT31

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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