The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1952-2023·Announced 2023-07-05

FDA Recalls Teleflex Endotracheal Tubes for Connector Disconnection

The FDA is recalling approximately 302,652 Teleflex preformed oral endotracheal tubes nationwide due to reports of disconnection between the 15mm connector and the tube. Healthcare providers should immediately discontinue use of affected units.

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 of Severe (score 4). Although no illnesses or injuries are reported in the source, the potential for device failure in a critical airway management device poses significant risk.

Plain-English summary

Teleflex LLC is recalling approximately 302,652 units of Preformed AGT Oral Endotracheal Tubes (REF 111781050) distributed nationwide, including Puerto Rico.

The FDA classified this as a Class I recall due to reports of disconnection of the 15mm connector from the endotracheal tube. The 15mm connector secures the tube to other medical equipment during use.

Healthcare providers should immediately cease using affected units identified by batch numbers and UDI 14026704341181. Report any instances of connector disconnection to Teleflex LLC or the FDA.

The recalled product

Product
Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111781050
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
302,652

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 14026704341181
  • Batch Numbers: 18FG31
  • 18FT35
  • 18FT39
  • 18GG17
  • 18GG18
  • 18GT32
  • 18HG17
  • 18HG19
  • 18HG21
  • 18HG22
  • 18HG29
  • 18IG15
  • 18IG17
  • 18IG30
  • 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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