The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1959-2023·Announced 2023-07-05

Endotracheal Tubes Recalled for Potential 15mm Connector Disconnection

TELEFLEX is recalling 4,160 endotracheal tubes due to reports of the 15mm connector disconnecting from the tube. Affected units were 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 Class I classification mandates a minimum severity rating of 4. Although no deaths, hospitalizations, or injuries have been reported, connector disconnection on an endotracheal tube presents serious potential harm.

Plain-English summary

TELEFLEX LLC is recalling 4,160 units of Endotracheal Tubes oral/nasal Magill with High Volume, Low Pressure Cuff (model REF 112080060). Reports indicate that the 15mm connector can disconnect from the endotracheal tube.

The affected tubes were distributed nationwide throughout the United States and Puerto Rico across multiple batch numbers.

The FDA classified this as a Class I recall, the most serious category. Healthcare providers and patients currently using these tubes should stop use and contact TELEFLEX LLC immediately for guidance on replacement or safe handling. Any adverse events should be reported to the FDA.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080060
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway
Hazard
Affected units
4,160

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 14026704341266
  • Batch Numbers: 18GG26
  • 18GT08
  • 18GT11
  • 18IG22
  • 18IT18
  • 18JG33
  • 19AG39
  • 19ET31
  • 19GT25
  • 19IT20
  • 19KT14
  • 19KT47
  • 20AT58
  • 20CT13
  • 20FT66
  • KME20J1463
  • KME21K0521
  • KME22A2893
  • KME22B2215

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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