The Recall Desk

FDA (Devices) recall action 97733

Olympus Corporation of the Americas recalled 2 products on 2025-11-19

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
2025-11-19
Critical
0
Units
66,382

Why these products were recalled

Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.

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)··2025-11-19

    Fifteen millimetre snares recalled over holes compromising package sterility

    Olympus is recalling 18,174 Single Use Electrosurgical Snares SD-400U-15 because sterility may be compromised by small holes formed during packaging or transportation.

    Product
    Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgical Snare Model/Catalog Number: SD-U400U-15 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and
    Category
    Distribution
    2 states
  • HighFDA (Devices)··2025-11-19

    Electrosurgical snares recalled over small holes compromising package sterility

    Olympus is recalling 48,208 Single Use Electrosurgical Snares SD-400 because sterility may be compromised by small holes formed during packaging or transportation.

    Product
    Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catalog Number: SD-400U-10 Product Description: These instruments have been designed to be used with an Olympus endoscope for the removal and/or cauterization of di
    Category
    Distribution
    2 states