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Olympus Corporation of the Americas Recalls
414 recalls on record · October 7, 2015 to July 29, 2026 · Medical Devices
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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.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name: Everest Bipolar Cutting Forceps Mo
Hazard: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest Bipolar Cutting Forceps Model/Ca
Hazard: Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Reprocessor OER-Elite. Model Number: N5789340.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Air/Water Valve - MAJ-1444. Model Number: MAJ-1444.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
April 1, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Endoscope Suction Valve - MAJ-1443. Model Number: MAJ-1443.
Hazard: The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
March 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Re
Hazard: Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
March 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to
Hazard: Potential for rubber fragment detachment during use.
March 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be
Hazard: Potential for rubber fragment detachment during use.
March 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog
Hazard: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
March 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes
Hazard: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
March 11, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes M
Hazard: Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gynecological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applicatio
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic application
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applicatio
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.
March 4, 2026Medical DevicesFDA
Olympus Corporation of the Americas recalls Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Hazard: Complaints of the ceramic tip of the resection sheath breaking have been received.