Olympus Corporation of the Americas: Device Recall

Recall #Z-0229-2025 · 08/23/2024

Class II: Risk

Recall Details

Recall Number: Z-0229-2025
Classification: Class II
Product Type: Device
Recalling Firm: Olympus Corporation of the Americas
Status: Ongoing
Date Initiated: 08/23/2024
Location: Center Valley, PA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 445 units

Reason for Recall

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.

Product Description

Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)

Distribution Pattern

US Nationwide distribution.

Other Recalls by Olympus Corporation of the Americas

Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.

View all recalls by Olympus Corporation of the Americas →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.