The Recall Desk

FDA (Devices) recall action 85689

Covidien Llc recalled 4 products on 2020-06-10

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
2020-06-10
Critical
0
Units
50,440

Why these products were recalled

The product is recalled due to a manufacturing assembly error that may cause the staples to fail to properly advance within the staple cartridge when the instrument handle is compressed.

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

  • HighFDA (Devices)··2020-06-10

    FDA Recalls Multifire VersaTrack Auto Suture Hernia Stapler Due to Assembly Error

    The FDA is recalling 12,610 units of the Multifire VersaTrack Auto Suture Hernia Stapler because a manufacturing error may cause staples to fail to advance properly.

    Product
    Multifire VersaTrack Auto Suture Hernia Stapler, 4.0mm, Part No. 174021 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-06-10

    Multifire Endo Hernia Stapler Recalled for Manufacturing Assembly Error

    Covidien is recalling Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly during use.

    Product
    Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit , Part No. 174025 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-06-10

    FDA Recalls Multifire Endo Hernia Staplers Due to Assembly Error

    The FDA is recalling 12,610 Multifire Endo Hernia Staplers due to a manufacturing error that may cause staples to fail to advance properly.

    Product
    Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit , Part No. 174027 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-06-10

    FDA Recalls Multifire VersaTrack Auto Suture Hernia Stapler Due to Assembly Error

    The FDA is recalling 12,610 units of the Multifire VersaTrack Auto Suture Hernia Stapler because a manufacturing error may prevent staples from advancing properly.

    Product
    Multifire VersaTrack Auto Suture Hernia Stapler, 4.8mm, Part No. 174023 - Product Usage: has application in endoscopic general surgery procedures for fixation of mesh in the repair of hernial defects and in other surgical specialties for approximation of tissue(s).
    Category
    Distribution
    0 states