The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1874-2023·Announced 2023-07-05

Endotracheal Tube Recall Due to 15mm Connector Disconnection

TELEFLEX is recalling endotracheal tubes due to reports of 15mm connector disconnection. Approximately 25,160 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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: This recall meets the FDA Class I classification, the highest severity level for products where there is reasonable probability of serious adverse health consequences or death. A disconnected endotracheal tube connector can cause immediate airway loss in ventilated patients, which is life-threatening.

Plain-English summary

TELEFLEX LLC is recalling endotracheal tubes (Murphy style, REF 100382030) following reports of disconnection of the 15mm connector. The recall affects approximately 25,160 units distributed nationwide, including Puerto Rico.

Endotracheal tubes are breathing tubes used to maintain an open airway during mechanical ventilation, anesthesia, or emergency care. When the 15mm connector disconnects from the tube, the seal is broken, which can disrupt ventilation and pose serious risk to patient safety.

Healthcare facilities should immediately discontinue use of affected units and verify inventory against the provided batch numbers using UDI/DI code 14026704340795. Specific batch numbers are listed in the FDA recall notice.

Any reported incidents of connector disconnection should be reported immediately to TELEFLEX or the FDA.

The recalled product

Product
Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030
Manufacturer
TELEFLEX LLC
Category
Medical Device — Respiratory / Airway Management
Hazard
Affected units
25,160

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 14026704340795
  • Batch Numbers: 18FT13
  • 18GT32
  • 18HG08
  • 18HG25
  • 18IG29
  • 18JG35
  • 18KG08
  • 18LG23
  • 19AG08
  • 19AG23
  • 19AG38
  • 19BG12
  • 19BG35
  • 19CT37
  • 19CT42
  • 19DT36
  • 19ET51
  • 19FT08
  • 19GT05

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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