The Recall Desk

FDA (Devices) recall action 70275

Intuitive Surgical, Inc. recalled 2 products on 2015-02-25

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
2015-02-25
Critical
0
Units
24,934

Why these products were recalled

Internal labeling review found that the IFU for the Harmonic Ace incorrectly instructs the user on how to manually open the grips.

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

1–2 of 2

  • ModerateFDA (Devices)··2015-02-25

    Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use

    Intuitive Surgical is recalling Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.

    Product
    HARMONIC ACE Curved Shears Instructions for Use, 5MM, IS1200; for use with the da Vinci Standard Surgical System. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surgical System
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2015-02-25

    Intuitive Surgical Recalls Harmonic Ace Curved Shears Instructions for Use

    Intuitive Surgical is recalling 12,467 Harmonic Ace Curved Shears Instructions for Use because they incorrectly instruct users on how to manually open the grips.

    Product
    HARMONIC ACE Curved Shears Instructions for Use, 8MM, IS2000/IS3000; for use with the da Vinci Surgical System - IS2000 and IS3000. Intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is used in conjunction with the da Vinci Surg
    Category
    Distribution
    1 state