The Recall Desk

FDA (Devices) recall action 55358

Karl Storz Endoscopy America Inc recalled 12 products on 2013-05-22

The FDA (Devices) publishes a recall like this one as 12 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 12 pages.

Products
12
Announced
2013-05-22
Critical
0
Units
113,184

Why these products were recalled

Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, which may result in airborne contamination.

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.

1–12 of 12

  • HighFDA (Devices)··2013-05-22

    Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage

    Karl Storz is recalling 9,432 units of sterile electrode accessories because damaged packaging may allow airborne contamination.

    Product
    Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Recalls Pointed Coagulation Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 units of pointed coagulation electrodes because damage to the sterile blister tray packaging may allow airborne contamination.

    Product
    Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Cutting Loops Recalled for Packaging Damage

    Karl Storz is recalling 9,432 cutting loops due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-05-22

    Karl Storz Cutting Loops Recalled for Potential Sterile Packaging Damage

    Karl Storz is recalling specific cutting loops due to possible damage to sterile packaging, which may result in airborne contamination.

    Product
    Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Recalls Roller Ball Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 Roller Ball Electrodes because damaged sterile packaging may allow airborne contamination.

    Product
    Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Cutting Electrode Recall Due to Packaging Damage

    Karl Storz is recalling cutting electrodes because damaged sterile packaging may allow airborne contamination.

    Product
    Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Cutting Electrodes Recalled for Packaging Damage

    Karl Storz is recalling 9,432 cutting electrodes due to possible damage to sterile packaging that may allow airborne contamination.

    Product
    Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Recalls Sterile Electrodes Due to Packaging Damage

    Karl Storz is recalling 9,432 sterile ball-end electrodes because damaged packaging may allow airborne contamination.

    Product
    Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Recalls Sterile Electrode Accessories Due to Packaging Damage

    Karl Storz is recalling 9,432 sterile electrode accessories because damaged packaging may allow airborne contamination.

    Product
    Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Cutting Electrode Recall Due to Packaging Damage

    Karl Storz is recalling 9,432 cutting electrodes due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz VaporCut Electrode Recalled for Packaging Damage

    Karl Storz is recalling 9,432 VaporCut electrodes due to possible sterile packaging damage that may allow airborne contamination.

    Product
    Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-05-22

    Karl Storz Recalls Cold Straight Knives Due to Packaging Damage

    Karl Storz is recalling 9,432 units of cold straight knives because damaged sterile packaging may allow airborne contamination.

    Product
    Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode, cutting loops and cold knives).
    Category
    Distribution
    0 states