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Aizu Olympus Co., Ltd. FDA Recalls
31 recalls on file across devices, 0 of them Class I and 30 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Olympus OER-MiniClass IIOct 31, 2025Inform existing affected device customers about pertinent Wa |
| Olympus OER-EliteClass IIOct 31, 2025Inform existing affected device customers about pertinent Wa |
| Olympus OER-ProClass IIOct 31, 2025Inform existing affected device customers about pertinent Wa |
| GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEClass IIOct 16, 2023Specific devices may have an improperly repaired light guide |
| GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPEClass IIOct 16, 2023Specific devices may have an improperly repaired light guide |
| PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPEClass IIOct 16, 2023Specific devices may have an improperly repaired light guide |
| CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPEClass IIOct 16, 2023Specific devices may have an improperly repaired light guide |
| PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPEClass IIOct 16, 2023Specific devices may have an improperly repaired light guide |
| Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided needle aspiration and other endoscopic procedClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) and for endoscopic surgery within the upper Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Colonoscope-indicated for use within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ilClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasound guided needle aspiration and other endoscClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Gastrointestinal videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60.Class IIISep 25, 2023Channel air drying process was not validated, and that a sma |
| Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Cystonephroscope-endoscopic diagnosis and treatment within the bladder, urethra, and kidney Model Numbers: CYF-5, CYF-VClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Colonoscope: for endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for endoscopy and enClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number: HYF-XP.Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and manageClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Bronchoscope-for endoscopy and endoscopic surgery within the airways and tracheobronchial tree. Model Numbers: BF-1T15Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidney and biliary tract (common bile duct and Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Small intestinal videoscope-For endoscopy and endoscopic surgery within the upper digestive tract (including the esophagClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T.Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ureter and kidney. Model Numbers: URF-P7, UClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum anClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Tracheal fiberscope-airway management, which includes observation to access airway anatomy, endotracheal/endobronchial iClass IISep 25, 2023Channel air drying process was not validated, and that a sma |
| Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: HYF-V.Class IISep 25, 2023Channel air drying process was not validated, and that a sma |
| EVIS EXERA III BronchovideoscopeClass IIJul 20, 2022The recalled unit was utilized in a veterinary endoscopy pro |