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Olympus Corporation of the Americas Recalls
414 recalls on record · October 7, 2015 to July 29, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software V
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0330; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0730; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0720; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-431Q-0720 Product Description: These ins
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 Product Descriptio
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software
Hazard: Devices which did not undergo thermoforming could deform and lose performance.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Mode
Hazard: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
February 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Cata
Hazard: A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.
December 3, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V Model/Catalog Number: TJF-Q190V Product
Hazard: Continued reports of positive cultures and infections have identified updates to the reprocessing materials to minimize potential deviations in TJF duodenoscope reprocessing. Olympus is informing users of these changes, reminding users to closely follow the operation and reprocessing instructions, and providing updated materials to users.
December 3, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an
Hazard: Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy.
November 26, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephro
Hazard: Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
November 19, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Product Name: Single Use Single Use Electrosurgi
Hazard: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
November 19, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Single Use Electrosurgical Snare Model/Catal
Hazard: Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
November 19, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Transducer Model/Catalog Number: SPL-T Prod
Hazard: The device may either fail to start up, or the transducer may start briefly and then stop, accompanied by an error light on the generator. In addition, the body of the transducer handpiece may gradually increase in temperature during clinical use.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.
October 22, 2025Medical DevicesFDA
Olympus Corporation of the Americas recalls BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
Hazard: Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.