The Recall Desk

FDA (Devices) recall action 80066

Ethicon Endo-Surgery Inc recalled 2 products on 2018-06-06

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2018-06-06
Critical
0
Units
171,983

Why these products were recalled

The devices may have been assembled with an internal component that may cause continuous or inadvertent activation of the device.

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.

1–2 of 2

  • HighFDA (Devices)··2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 36cm Length / Curved, Product Code HAR36, GTIN 10705036014447 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2018-06-06

    Ethicon HARMONIC ACE Shears Recalled for Inadvertent Activation Risk

    Ethicon Endo-Surgery Inc is recalling HARMONIC ACE Shears because an internal component may cause continuous or inadvertent activation of the device.

    Product
    HARMONIC ACE Shears + Adaptive Tissue Technology, 5mm Diameter / 23cm Length / Curved, Product Code HAR23, GTIN 10705036014430 Product Usage: The HARMONIC ACE¿ Shears + Adaptive Tissue Technology are indicated for soft tissue incisions when bleeding control and minimal therma
    Category
    Distribution
    0 states