Aizu Olympus Co., Ltd.
FDA adverse event reports naming Aizu Olympus Co., Ltd. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: AIZU OLYMPUS CO., LTD..
- Total reports
- 159,910
- Deaths
- 93
- Injuries
- 2,709
- Malfunctions
- 157,108
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Top device categories
- Gastroscope And Accessories, Flexible/RigidFDS56,566
- Colonoscope And Accessories, Flexible/RigidFDF52,512
- Bronchoscope (Flexible Or Rigid)EOQ20,607
- Duodenoscope And Accessories, Flexible/RigidFDT14,846
- Laparoscope, General & Plastic SurgeryGCJ7,892
- Ureteroscope And Accessories, Flexible/RigidFGB3,651
- Accessories, Cleaning, For EndoscopeFEB2,683
- Enteroscope And AccessoriesFDA397
- Cystoscope And Accessories, Flexible/RigidFAJ263
- Choledochoscope And Accessories, Flexible/RigidFBN168
Recent recalls
- 2025-12-02Open, ClassifiedUnder Investigation by firm
Olympus OER-Elite
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2025-12-02Open, ClassifiedUnder Investigation by firm
Olympus OER-Pro
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2025-12-02Open, ClassifiedUnder Investigation by firm
Olympus OER-Mini
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- 2023-11-29Open, ClassifiedProcess control
CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
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.
- 2023-11-29Open, ClassifiedProcess control
GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
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.
- 2023-11-29Open, ClassifiedProcess control
GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
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.
- 2023-11-29Open, ClassifiedProcess control
PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
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.
- 2023-11-29Open, ClassifiedProcess control
PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
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.
- 2023-11-17Open, ClassifiedUnder Investigation by firm
Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T150, BF-1T60, BF-1TH190, BF-1TQ170, BF-3C160, BF-3C40, BF-H190, BF-MP190F, BF-MP60, BF-P150, BF-P190, BF-P60, BF-Q170, BF-Q190, BF-XP190, BF-XP60, BF-XT160, BF-XT190. 510(k)s: K023984, K121959, K963033, K172726, K201758, K033225, K183419.
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
- 2023-11-17Open, ClassifiedUnder Investigation by firm
Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscopic procedures within the airways, trancheobronchial tree, esophagus and surrounding organs Model Numbers: BF-UC180F, BF-UC190F.
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
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