The Recall Desk
HighFDA (Devices)·Z-1012-2023·Announced 2023-02-01

Teleflex Endotracheal Tubes Recalled for Potential Cuff and Balloon Dysfunction

Teleflex is recalling approximately 497 endotracheal tubes worldwide due to potential failure of pilot balloon inflation or cuff deflation, which could interfere with airway management.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall with no reported illnesses or injuries in the source text. The hazard—potential pilot balloon non-inflation or cuff non-deflation—presents a risk of serious airway management complications in patients requiring intubation, fitting the 'risk-of-harm' criterion for Score 3.

Plain-English summary

Teleflex LLC is recalling multiple models of endotracheal tubes due to potential dysfunction in cuff and pilot balloon operation. Affected products include oral/nasal Magill, Murphy Eye, Flexiset Super Safety Clear, and RUSCHELIT Safety Clear variants manufactured by Teleflex.

The recalled tubes may fail to properly inflate the pilot balloon or deflate the cuff. Such malfunction could compromise the ability to manage the airway in patients requiring endotracheal intubation.

Approximately 497 units have been distributed globally, with documented distribution in multiple countries and U.S. states. Affected product codes and batch numbers with UDI identifiers are specified in the FDA recall notice.

The recalled product

Product
Endotracheal Tube labeled as the following: a. Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. Flexiset Super Safety Clear Tracheal Tube, oral/nasal with Cuff and Inse
Manufacturer
TELEFLEX LLC
Category
Medical Device — Airway Management Equipment
Hazard
  • cuff-malfunction
  • pilot-balloon-failure

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)

  • Not distributed within the USA. a. Product Code
  • Batch Number (UDI): 112080-000065
  • KME21D2250 ((01)14026704195937(17)260328(10)KME21D2250)
  • 112080-000080
  • KME21E1336 ((01)14026704195968(17)260428(10)KME21E1336)
  • b. Product Code
  • Batch Number (UDI): 112082-000050
  • KME21F0726 ((01)14026704196019(17)260528(10)KME21F0726)
  • 112082-000055
  • KME21E1231 ((01)14026704196026(17)260428(10)KME21E1231)
  • KME21F0945 ((01)14026704196026(17)260528(10)KME21F0945)
  • 112082-000060
  • KME21E1395 ((01)14026704196033(17)260428(10)KME21E1395)
  • 112082-000065
  • KME21F0383 ((01)14026704196040(17)260528(10)KME21F0383)
  • KME21F0833 ((01)14026704196040(17)260528(10)KME21F0833)
  • KME21F0931 ((01)14026704196040(17)260528(10)KME21F0931)
  • 112082-000070
  • KME21E0582 ((01)14026704196057(17)260428(10)KME21E0582)
  • KME21E1267 ((01)14026704196057(17)260428(10)KME21E1267)

Distribution

Distributed nationwide across the United States.

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