The Recall Desk

FDA (Devices) recall action 99300

Boston Scientific Corporation recalled 3 products on 2026-08-12

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2026-08-12
Critical
0
Units
—

Why these products were recalled

Potential for breach in sterile barrier of device packaging.

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

States named across these recalls

1–3 of 3

  • SevereFDA (Devices)··2026-08-12

    Radial Jaw 4 Jumbo Biopsy Forceps Packaging Sterile Barrier Recall

    Boston Scientific is recalling Radial Jaw 4 Jumbo Biopsy Forceps due to potential breach in the sterile barrier of device packaging. The recall affects 5,020 units in the US and 20,770 units outside the US.

    Product
    Radial Jaw 4 Jumbo Biopsy Forceps with the following descriptions and UPN: Radial Jaw 4 Jumbo 240cm Box 5; Outer Box UPN: M00513363; Inner Box UPN: M00513360.
    Category
    Distribution
    33 states
  • HighFDA (Devices)··2026-08-12

    Biopsy Forceps Recall: Sterile Packaging Breach Risk

    Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging, which could compromise sterility.

    Product
    Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial J
    Category
    Distribution
    33 states
  • ModerateFDA (Devices)··2026-08-12

    Boston Scientific Radial Jaw 4 Biopsy Forceps Recalled Due to Sterile Barrier Breach Risk

    Boston Scientific Corporation is recalling specific Radial Jaw 4 Standard Capacity Biopsy Forceps because there is a potential for a breach in the sterile barrier of the device packaging.

    Product
    Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20; Outer Box UPN: M00513401; Inner Box UPN: M00513400. 2. Radial Jaw 4 SC 240cm Box 40; Outer Box UPN: M00513402; Inner Box UPN: M00513400. 3. Radia
    Category
    Distribution
    33 states