The Recall Desk

FDA (Devices) recall action 61942

Covidien LP recalled 5 products on 2012-06-27

The FDA (Devices) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2012-06-27
Critical
0
Units
123,856

Why these products were recalled

Potential for the sterility barrier to be compromised.

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

1–5 of 5

  • SevereFDA (Devices)··2012-06-27

    FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of Covidien ROTICULATOR 55-3.5 Single Use Staplers because the sterility barrier may be compromised, posing a risk of infection during surgery.

    Product
    Covidien ROTICULATOR 55-3.5 Single Use Stapler REF# 017612 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2012-06-27

    FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of Covidien ROTICULATOR 30-3.5 Single Use Staplers because the sterility barrier may be compromised, potentially affecting surgical safety.

    Product
    Covidien ROTICULATOR 30-3.5 Single Use Stapler REF# 017615 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-06-27

    FDA Recalls Covidien ROTICULATOR Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of the Covidien ROTICULATOR 30-4.8 Single Use Stapler because the sterility barrier may be compromised.

    Product
    Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2012-06-27

    FDA Recalls Covidien Roticalator Staplers Due to Sterility Barrier Risk

    The FDA is recalling 13,531 units of the Covidien ROTICULATOR 55-4.8 Single Use Stapler because the sterility barrier may be compromised.

    Product
    Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2012-06-27

    FDA Recalls Covidien Roticalutor Staplers Due to Sterility Barrier Risk

    The FDA is recalling specific lots of the Covidien Roticalutor 30-V3 Single Use Stapler because the sterility barrier may be compromised.

    Product
    Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis
    Category
    Distribution
    1 state