The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-1891-2023·Announced 2023-07-05

Teleflex Endotracheal Tubes Recalled for 15mm Connector Disconnection

Teleflex is recalling approximately 39,550 endotracheal tubes due to reports of 15mm connector disconnection. The FDA Class I recall affects units distributed nationwide including Puerto Rico.

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: Per the severity rubric, FDA Class I recalls require a minimum score of 4. Although the source text does not report illnesses or deaths, only connector disconnection incidents, the Class I designation indicates the FDA determined this hazard poses a serious patient safety risk.

Plain-English summary

Teleflex LLC is recalling 39,550 units of Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff (REF 112082085, UDI/DI 14026704341457) due to reported disconnection of the 15mm connector.

The affected devices were distributed nationwide throughout the United States and Puerto Rico. This is a Class I recall, the FDA's highest-priority classification for medical device recalls, indicating a serious patient safety hazard. Affected units are identified by UDI/DI 14026704341457, with batch numbers listed in the official FDA recall notice.

The recalled product

Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082085
Manufacturer
TELEFLEX LLC
Affected units
39,550

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 14026704341457
  • Batch Numbers: 18HG37
  • 18HT15
  • 18HT24
  • 18JG12
  • 18JG31
  • 19CT69
  • 19CT73
  • 19CT74
  • 19CT76
  • 19CT77
  • 19DT05
  • 19DT10
  • 19KT14
  • 19KT30
  • 19KT46
  • 19KT49
  • 19KT50
  • 19KT55
  • 19LT35

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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