The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1873-2023·Announced 2023-07-05

Preformed Endotracheal Tube Connectors May Disconnect During Medical Use

TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tubes due to reports of connector disconnection during use, affecting approximately 54,469 units 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 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 classification as Class I requires a severity score of at least 4. The source reports connector disconnection incidents but does not document deaths or hospitalizations, placing this at Severe rather than Critical.

Plain-English summary

TELEFLEX LLC is recalling Preformed AGT Oral Endotracheal Tubes (uncuffed/plain Murphy model, REF 100181050) distributed nationwide in the United States and Puerto Rico. Approximately 54,469 units are affected, identified by UDI/DI 14026704340566 and specific batch numbers.

The tubes are being recalled because the 15mm connector may disconnect from the endotracheal tube. Reports of this disconnection prompted the U.S. Food and Drug Administration to issue a Class I recall designation.

Endotracheal tubes are used in medical settings to secure airways during anesthesia, surgery, and critical care. The potential for connector disconnection raises patient safety concerns in healthcare facilities using these products. Medical facilities and healthcare providers can verify whether they have affected products using the batch numbers provided by the FDA.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050
Manufacturer
TELEFLEX LLC
Category
Medical Device — Endotracheal Tube
Hazard
Affected units
54,469

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 14026704340566
  • Batch Numbers: 18FG31
  • 18FT35
  • 18GG23
  • 18GT32
  • 18HG17
  • 18JG19
  • 18JG21
  • 18JG37
  • 18KG18
  • 18KG19
  • 18KG21
  • 18KG38
  • 18KG39
  • 18LG14
  • 19AG01
  • 19BG02
  • 19BG18
  • 19CG01
  • 19CG02

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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