Aizu Olympus Co., Ltd.
Complete recall history across all FDA and CPSC categories — 31 total recalls
Aizu Olympus Co., Ltd. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (31)
FDA medical device enforcement actions by Aizu Olympus Co., Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 31, 2025 | Olympus OER-Mini | Inform existing affected device customers about pertinent Warnings/Cautions, ... | Class II |
| Oct 31, 2025 | Olympus OER-Pro | Inform existing affected device customers about pertinent Warnings/Cautions, ... | Class II |
| Oct 31, 2025 | Olympus OER-Elite | Inform existing affected device customers about pertinent Warnings/Cautions, ... | Class II |
| Oct 16, 2023 | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to... | Class II |
| Oct 16, 2023 | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to... | Class II |
| Oct 16, 2023 | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to... | Class II |
| Oct 16, 2023 | PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to... | Class II |
| Oct 16, 2023 | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to... | Class II |
| Sep 25, 2023 | Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ure... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Mobile airway scope-diagnosis and observation to access airway anatomy, endot... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided ne... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Colonoscope: for endoscopy and endoscopic surgery within the lower digestive ... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Small intestinal videoscope-For endoscopy and endoscopic surgery within the u... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number:... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and oth... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Gastrointestinal videoscope-indicated for use within the upper digestive trac... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: H... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Tracheal videoscope- For airway management, which includes observation to acc... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Cystonephroscope-endoscopic diagnosis and treatment within the bladder, ureth... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidn... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasoun... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Colonoscope-indicated for use within the lower digestive tract (including the... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lum... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Bronchoscope-for endoscopy and endoscopic surgery within the airways and trac... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. | Channel air drying process was not validated, and that a small percentage of ... | Class III |
| Sep 25, 2023 | Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) a... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Tracheal fiberscope-airway management, which includes observation to access a... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Sep 25, 2023 | Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower dig... | Channel air drying process was not validated, and that a small percentage of ... | Class II |
| Jul 20, 2022 | EVIS EXERA III Bronchovideoscope | The recalled unit was utilized in a veterinary endoscopy procedure in advance... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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