The Recall Desk

FDA (Devices) recall action 88434

Ethicon Endo-Surgery Inc recalled 2 products on 2021-09-01

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
2021-09-01
Critical
0
Units
76,830

Why these products were recalled

An internal component may be cracked and become lodged behind the energy button potentially resulting in continuous activation of the device, may result in burns

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)··2021-09-01

    HARMONIC HD 1000i Surgical Shears Recalled for Potential Burn Risk

    Ethicon is recalling HARMONIC HD 1000i Shears because an internal component may crack and lodge behind the power button, causing continuous unintended activation and potential burns. Affected users should discontinue use immediately.

    Product
    HARMONIC HD 1000i Shears (20cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD20
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-09-01

    Surgical Shears HARMONICHD 1000i Recalled Due to Component Defect and Burn Risk

    Ethicon is recalling HARMONICHD 1000i Shears due to a cracked internal component that may cause continuous device activation and result in burns. About 68,960 units have been distributed worldwide.

    Product
    HARMONICHD 1000i Shears (36cm Shaft Length)-indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. Product Code: HARHD36
    Category
    Distribution
    0 states