Olympus Corporation of the Americas
133 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Olympus Corporation of the Americas and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
- 2026-03-04FDA-DeviceClass IIOlympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;
Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat 5 mm, 10 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat, 5 mm, 20 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat, 5 mm, 35 cm, Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat, 5 mm, 45 cm Inline Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IIOlympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Firm is initiating a removal due to continued reports of adverse events.
- 2026-02-25FDA-DeviceClass IOlympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
- 2026-02-25FDA-DeviceClass IOlympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
- 2026-02-25FDA-DeviceClass IOlympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
Issue with software algorithm which may lead to overpressure events.
- 2026-02-11FDA-DeviceClass IIProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
- 2026-02-11FDA-DeviceClass IIBrand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
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