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Aizu Olympus Co., Ltd.

US Last updated 23 May 2026

Devices
1
Registries
FDA 510(k)FDA
FDA recalls
3130 ongoing

Catalogue1

FDA recalls31

Recalls this firm reported to the FDA. Device pages show the recalls that name the device or the 510(k)/PMA it was cleared under.

Showing the 10 most recent of 31 recalls.

  • 2025

    • 31 Oct 2025 Z-0872-2026 Class II Ongoing Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
    • 31 Oct 2025 Z-0873-2026 Class II Ongoing Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
    • 31 Oct 2025 Z-0874-2026 Class II Ongoing Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.

  • 2023

    • 16 Oct 2023 Z-0415-2024 Class II Ongoing Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
    • 16 Oct 2023 Z-0416-2024 Class II Ongoing Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
    • 16 Oct 2023 Z-0417-2024 Class II Ongoing Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
    • 16 Oct 2023 Z-0418-2024 Class II Ongoing Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
    • 16 Oct 2023 Z-0419-2024 Class II Ongoing Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.
    • 25 Sep 2023 Z-0327-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0328-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Show the 25 most recent of 31 recalls

  • 2023

    • 25 Sep 2023 Z-0329-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0330-2024 Class III Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0331-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0332-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0333-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0334-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0335-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0336-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0337-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0338-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0339-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0340-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0341-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0342-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
    • 25 Sep 2023 Z-0343-2024 Class II Ongoing Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Aizu Olympus Co., Ltd. AIZUWAKAMATSU-SHI Fukushima · JP FEI 3002964398

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