The Recall Desk

FDA (Devices) recall action 79435

Microline Surgical, Inc. recalled 2 products on 2018-05-16

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
2018-05-16
Critical
0
Units
—

Why these products were recalled

Certain lots of disposable laparoscopic instrument tips may potentially have a compromised sterile barrier.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2018-05-16

    Microline Surgical Recalls ReNew Dolphin Nose Disposable Dissector Tips

    Microline Surgical is recalling specific lots of ReNew Dolphin Nose Disposable Dissector Tips due to a potentially compromised sterile barrier.

    Product
    ReNew Dolphin Nose Disposable Dissector Tip, Catalog Number: 3312, UDI: 00811099011989 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in…
    Category
    Distribution
    5 states
  • HighFDA (Devices)··2018-05-16

    Microline Surgical Recalls ReNew Endocut Scissor Tips Due to Sterility Concerns

    Microline Surgical is recalling specific lots of ReNew Endocut Scissor Disposable Tips because the sterile barrier may be compromised.

    Product
    ReNew Endocut Scissor Disposable Tip, Catalog Number: 3142, UDI: 00811099012115 The ReNew single patient use disposable tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting, grasping, dissecting and coagulation of tissue in endoscopic…
    Category
    Distribution
    5 states