The Recall Desk

FDA (Devices) recall action 79905

Covidien LLC recalled 2 products on 2018-05-02

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
2018-05-02
Critical
0
Units
6,022

Why these products were recalled

There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.

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

  • HighFDA (Devices)··2018-05-02

    EEA Hemorrhoid Stapler Recalled for Potential Welding Defect

    FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed…
    Category
    Distribution
    27 states
  • HighFDA (Devices)··2018-05-02

    Recall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect

    Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed…
    Category
    Distribution
    27 states