The Recall Desk

FDA (Devices) recall action 98243

Olympus Corporation of the Americas recalled 3 products on 2026-02-25

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
2026-02-25
Critical
1
Units
1,247

Why these products were recalled

Issue with software algorithm which may lead to overpressure events.

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.

1–3 of 3

  • SevereFDA (Devices)··2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Overpressure Risk

    Olympus is recalling 485 High Flow Insufflation Units (Model UHI-3) nationwide due to a software algorithm issue that may cause dangerous overpressure during abdominal surgery.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2026-02-25

    Olympus High Flow Insufflation Unit Recalled Due to Software Algorithm Issue

    Olympus Corporation of the Americas is recalling the Olympus High Flow Insufflation Unit (Model UHI) because a software algorithm issue may cause overpressure events.

    Product
    Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2026-02-25

    Olympus High Flow Insufflation Unit Model UHI-2 Recalled Due to Software Issue

    Olympus Corporation of the Americas is recalling 744 Olympus High Flow Insufflation Units (Model UHI-2) because a software algorithm issue may cause overpressure events.

    Product
    Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
    Category
    Distribution
    0 states