The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1960-2023·Announced 2023-07-05

Endotracheal Tubes Recalled Due to 15mm Connector Disconnection Reports

TELEFLEX LLC is recalling 6,710 endotracheal tubes due to reports of 15mm connector disconnection. This Class I recall affects 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 classified as FDA Class I, the highest regulatory classification for medical device recalls. Although no reported illnesses or injuries are documented in the source, disconnection of the airway connector presents a serious patient safety risk.

Plain-English summary

TELEFLEX LLC is recalling 6,710 Endotracheal Tube oral/nasal Magill units (REF 112080065) with High Volume, Low Pressure Cuff due to reports of disconnection of the 15mm connector from the endotracheal tube.

The endotracheal tube is a medical device used for airway management. The 15mm connector is critical for maintaining a secure connection during ventilation. Disconnection of this connector could result in loss of ventilation.

The recalled units were distributed nationwide in the United States, including Puerto Rico. Batch numbers include: 18GT07, 18HG20, 18IG16, 18IG22, 18JG13, 19AT23, 19CT64, 19ET12, 19ET31, 19HT69, 19LT47, 20AT41, 20BT13, 20DT40, 20GT05, KME22A2193, KME22A2546, KME22B2739, KME22C2271, KME22E0189.

The recalled product

Product
Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management
Hazard
Affected units
6,710

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: 18GT07
  • 18HG20
  • 18IG16
  • 18IG22
  • 18JG13
  • 19AT23
  • 19CT64
  • 19ET12
  • 19ET31
  • 19HT69
  • 19LT47
  • 20AT41
  • 20BT13
  • 20DT40
  • 20GT05
  • KME22A2193
  • KME22A2546
  • KME22B2739
  • KME22C2271

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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