Aizu Olympus Co., Ltd.
FDA Regulatory Profile
Aizu Olympus Co., Ltd. appears in FDA public data with 31 recalls, 1 510(k) clearance, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0874-2026, Class II) was initiated on October 31, 2025. Its most recent 510(k) clearance was granted on January 28, 2005.
Summary
- Total Recalls
- 31
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0874-2026 | Class II | Olympus OER-Mini | October 31, 2025 |
| Z-0873-2026 | Class II | Olympus OER-Pro | October 31, 2025 |
| Z-0872-2026 | Class II | Olympus OER-Elite | October 31, 2025 |
| Z-0417-2024 | Class II | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | October 16, 2023 |
| Z-0418-2024 | Class II | PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE | October 16, 2023 |
| Z-0415-2024 | Class II | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | October 16, 2023 |
| Z-0416-2024 | Class II | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | October 16, 2023 |
| Z-0419-2024 | Class II | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE | October 16, 2023 |
| Z-0347-2024 | Class II | Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (c | September 25, 2023 |
| Z-0340-2024 | Class II | Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial i | September 25, 2023 |
| Z-0328-2024 | Class II | Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspirat | September 25, 2023 |
| Z-0344-2024 | Class II | Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. | September 25, 2023 |
| Z-0334-2024 | Class II | Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esopha | September 25, 2023 |
| Z-0345-2024 | Class II | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and oth | September 25, 2023 |
| Z-0335-2024 | Class II | Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. | September 25, 2023 |
| Z-0341-2024 | Class II | Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid | September 25, 2023 |
| Z-0330-2024 | Class III | Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. | September 25, 2023 |
| Z-0331-2024 | Class II | Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model N | September 25, 2023 |
| Z-0336-2024 | Class II | Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V. | September 25, 2023 |
| Z-0337-2024 | Class II | Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP. | September 25, 2023 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K043487 | EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 | January 28, 2005 |