The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1962-2023·Announced 2023-07-05

FDA recalls Teleflex endotracheal tubes for connector disconnection

Teleflex endotracheal tubes with high-volume, low-pressure cuffs are recalled due to reports of 15mm connector disconnection. The recall affects 13,810 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: This is an FDA Class I recall. Per the severity rubric, FDA Class I recalls receive a minimum severity of Severe (4). No deaths or reported illnesses are noted in the source.

Plain-English summary

The U.S. Food and Drug Administration is recalling the Endotracheal Tube oral/nasal Magill model with High Volume, Low Pressure Cuff (REF 112080075), manufactured by Teleflex LLC.

The recall is due to reports of disconnection of the 15mm connector from the endotracheal tube. Affected batches include multiple lots from 18FT26 through KME22F2118.

The recall affects 13,810 units distributed nationwide in the United States and Puerto Rico. This is classified as a Class I recall by the FDA.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
13,810

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 Batch Numbers: 18FT26
  • 18GG17
  • 18GG19
  • 18HG15
  • 18HG37
  • 18IG04
  • 18IG29
  • 18JG17
  • 18KG10
  • 19AT23
  • 19CT64
  • 19ET12
  • 19ET24
  • 19GT31
  • 19HT69
  • 19IT11
  • 20AT22
  • 20BT13
  • 20BT42
  • 20CT02

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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