The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1878-2023·Announced 2023-07-05

Endotracheal Tube Connector Disconnection Recall — Teleflex Preformed AGT Units

Teleflex is recalling 347,422 Preformed AGT Oral Endotracheal Tubes due to reports of 15mm connector disconnection. The connector may separate from the tube during use.

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 classification establishes a minimum severity score of 4 per recall guidance rules. The source documents reports of 15mm connector disconnection but does not report any associated deaths, injuries, or hospitalizations.

Plain-English summary

Teleflex LLC is recalling Preformed AGT Oral Endotracheal Tubes (Model REF 111781040) distributed nationwide, including Puerto Rico. The recall affects 347,422 units. The product is identified by UDI/DI 14026704341167 and specific batch numbers spanning designations 18FT35 through 20GT34 and additional KME-series lots.

The recall was initiated due to reports of disconnection of the 15mm connector from the endotracheal tube. The connector may separate from the tube during clinical use. Healthcare facilities and providers should identify any affected units using the complete list of batch numbers provided by the FDA in the official recall notice and consult Teleflex or the FDA for guidance on handling these devices.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781040
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway Equipment
Hazard
Affected units
347,422

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 14026704341167
  • Batch Numbers: 18FT35
  • 18GG16
  • 18GG19
  • 18GG23
  • 18GG34
  • 18GT32
  • 18HG17
  • 18HG21
  • 18HG22
  • 18HG29
  • 18HG30
  • 18IG15
  • 18JG01
  • 18JG03
  • 18JG16
  • 18JG19
  • 18JG35
  • 18JG37
  • 18KG17

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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