The Recall Desk

FDA (Devices) recall action 66063

Endoplus, Inc. recalled 2 products on 2013-10-02

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
2013-10-02
Critical
0
Units
90

Why these products were recalled

Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.

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)··2013-10-02

    Endoplus 5mm Laparoscopic Grasper Recalled for Broken Jaw

    Endoplus is recalling 81 units of 5mm Atraumatic Graspers because the moveable jaw broke during surgery. The devices were distributed in Florida, Texas, and Virginia.

    Product
    ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
    Category
    Distribution
    3 states
  • HighFDA (Devices)··2013-10-02

    Endoplus 5 mm Traumatic Grasper Recalled for Broken Jaw

    Endoplus is recalling 9 units of 5 mm Traumatic Graspers because the moveable jaw broke during laparoscopic procedures.

    Product
    ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, Standard; Non-sterile; Manufactured by Endoplus; 750 Tower Rd., Suite A, Mundelein, IL 60060 USA. Intended for grasping, dissecting, retraction, clamping in conjunction with the…
    Category
    Distribution
    3 states