The Recall Desk

FDA (Devices) recall action 67005

Ansell Sandel Medical Industries LLC recalled 7 products on 2014-01-15

The FDA (Devices) publishes a recall like this one as 7 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 7 pages.

Products
7
Announced
2014-01-15
Critical
0
Units
—

Why these products were recalled

Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–7 of 7

  • HighFDA (Devices)··2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades may be exposed, compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries LLC is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #11 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blade may be exposed beyond the safety shield, compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel 4# Disposable Safety Handle with #20 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, compromising sterility and posing an injury risk.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in China
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-01-15

    Sandel Weighted Safety Scalpels Recalled Due to Exposed Blades

    Ansell Sandel Medical Industries is recalling specific lots of Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #10 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in C
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2014-01-15

    Sandel Weighted Safety Scalpels Recalled for Exposed Blades

    Ansell Sandel Medical Industries is recalling Sandel Weighted Safety Scalpels because the blades are exposed beyond the safety shield, potentially compromising sterility and causing injury.

    Product
    Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Long Disposable Safety Handle with #15 Blade Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Made in C
    Category
    Distribution
    26 states