Aizu Olympus Recalls
31 recalls on record · August 31, 2022 to December 10, 2025 · Medical Devices
Recalls by year
22
23
25
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 10, 2025Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Olympus OER-Mini
Hazard: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
December 10, 2025Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Olympus OER-Pro
Hazard: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
December 10, 2025Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Olympus OER-Elite
Hazard: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
December 6, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Hazard: 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.
December 6, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE
Hazard: 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.
December 6, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Hazard: 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.
December 6, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE
Hazard: 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.
December 6, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE
Hazard: 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.
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, U
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and en
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic proced
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophag
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum an
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and manage
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronch
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial i
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and du
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasophary
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-V
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endosc
Hazard: 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
November 29, 2023Medical DevicesFDA
Aizu Olympus Co., Ltd. recalls Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T15
Hazard: 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