Drug & Device Safety Atlas

FDA recall record · openFDA

Aizu Olympus Co., Ltd.

30 FDA recalls on record (2023–2025) — 30 device. 30 still ongoing.

0
Class I (most serious)
29
Class II
1
Class III
30
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair h 22
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction cha 5
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules 3

Recalls

Olympus OER-Elite Class II 2025-10-31 Olympus OER-Pro Class II 2025-10-31 Olympus OER-Mini Class II 2025-10-31 PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE Class II 2023-10-16 Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum an Class II 2023-09-25 Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial i Class II 2023-09-25 Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper Class II 2023-09-25 Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T15 Class II 2023-09-25 Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasophary Class II 2023-09-25 Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and il Class II 2023-09-25 Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endosc Class II 2023-09-25 Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and Class II 2023-09-25 Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF- Class II 2023-09-25 PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE Class II 2023-10-16 CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE Class II 2023-10-16 Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-V Class II 2023-09-25 Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronch Class II 2023-09-25 Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. Class II 2023-09-25 Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and du Class II 2023-09-25 Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and en Class II 2023-09-25 Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. Class II 2023-09-25 GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Class II 2023-10-16 Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophag Class II 2023-09-25 Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid Class II 2023-09-25 Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic proced Class II 2023-09-25 Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and manage Class II 2023-09-25 Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. Class II 2023-09-25 GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE Class II 2023-10-16 Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, U Class II 2023-09-25 Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. Class III 2023-09-25

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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