The Recall Desk

FDA (Devices) recall action 91301

TELEFLEX LLC recalled 3 products on 2023-02-01

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2023-02-01
Critical
0
Units
42,457

Why these products were recalled

Potential for pilot balloon non-inflation or cuff non-deflation.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··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.

    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
    Category
    Distribution
    38 states
  • HighFDA (Devices)··2023-02-01

    Endotracheal tubes recalled for potential pilot balloon and cuff malfunction

    TELEFLEX LLC recalls 39,690 endotracheal tubes for potential pilot balloon non-inflation or cuff non-deflation. These critical airway devices may not function properly during patient intubation.

    Product
    Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended fo
    Category
    Distribution
    38 states
  • HighFDA (Devices)··2023-02-01

    Endotracheal Tubes May Fail to Inflate Pilot Balloon or Deflate Cuff

    TELEFLEX LLC is recalling 2,270 units of Slick Set Endotracheal Tubes due to potential pilot balloon non-inflation or cuff non-deflation. The devices were distributed worldwide including the United States.

    Product
    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal. Intended for patients requiring endotracheal intubation
    Category
    Distribution
    38 states