The Recall Desk

FDA (Devices) recall action 88826

Beaver Visitec International, Inc. recalled 4 products on 2021-11-24

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2021-11-24
Critical
0
Units
6,577

Why these products were recalled

Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades

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.

1–4 of 4

  • HighFDA (Devices)··2021-11-24

    Beaver Xstar Crescent Knife surgical blades recalled for specification mismatch

    Beaver Visitec is recalling CustomEyes surgical kits where Crescent Knives contain bevel-up blades instead of the specified bevel-down blades. The specification error could affect surgical precision during cataract procedures.

    Product
    bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component REF# 58000572 REF#: 373809
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-11-24

    Beaver Xstar Crescent Knife surgical blades may have incorrect bevel angle

    Approximately 5950 Beaver Xstar Crescent Knife surgical blades may be packaged with the wrong bevel angle, potentially affecting proper surgical technique during cataract procedures.

    Product
    Beaver Xstar Crescent Knife, 2.5mm, 55 degrees, bevel down. Intended for or cataract surgery. REF#: 373809
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-11-24

    Surgical Crescent Knife Recalled for Incorrect Blade Orientation Labeling

    Beaver Visitec International is recalling bvi CustomEyes Kits containing Crescent Knives due to incorrect labeling. Products labeled as 55-degree bevel-down blades actually contain bevel-up blades.

    Product
    bvi CustomEyes Kit-CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent Knife (REF#373809) as a component-non-sterile sample for evaluation purposes REF# BVI 58000587
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2021-11-24

    Beaver Xstar Crescent Knife Surgical Blades Recalled for Wrong Blade Orientation

    Beaver Visitec International recalls CustomEyes Cataract Surgical Kits containing Xstar Crescent Knives with incorrect blade orientation. Kits labeled as 55-degree bevel-down blades actually contain bevel-up blades.

    Product
    bvi CustomEyes Kit-AMO Germany GmbH Katarakt-set - Dr. Wagner: CustomEyes Cataract Surgical Kits that contain Beaver Xstar¿ Crescent Knife (REF#373809) as a component a) REF# 588221 REF#: 373809
    Category
    Distribution
    0 states