The Recall Desk

FDA (Devices) recall action 72749

Medtronic recalled 4 products on 2016-02-24

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2016-02-24
Critical
0
Units
1,797,442

Why these products were recalled

Staplers fail to fire or partially fire and reports of the instrument articulating lever disengaging during use

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.

1–4 of 4

  • SevereFDA (Devices)··2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Short Stapler Handles

    Medtronic is recalling 364,768 Endo GIA Ultra Universal Short Stapler Handles because they may fail to fire or partially fire, and the articulating lever may disengage during use.

    Product
    Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Stapler Handles in Best Practice Kits

    Medtronic is recalling 2,711 Best Practice Kits containing specific Endo GIA Ultra Universal Stapler Handles due to reports of staplers failing to fire or partially firing, and articulating levers disengaging during use.

    Product
    Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal Stapler Handles Due to Firing Defects

    Medtronic is recalling 1,102,166 Endo GIA Ultra Universal Standard Stapler Handles worldwide because they may fail to fire or partially fire during surgery.

    Product
    Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2016-02-24

    Medtronic Recalls Endo GIA Ultra Universal 12 mm XL Stapler Handles

    Medtronic is recalling 327,797 Endo GIA Ultra Universal 12 mm XL Stapler Handles worldwide because the staplers may fail to fire or the articulating lever may disengage during surgery.

    Product
    Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
    Category
    Distribution
    0 states