Open, ClassifiedPosted Feb 20, 2026·Initiated Nov 11, 2025
Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: ResectoscopeDistribution: US Nationwide Distribution.Recall #Z-1451-2026
Open, ClassifiedPosted Feb 20, 2026·Initiated Nov 11, 2025
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: ResectoscopeDistribution: US Nationwide Distribution.Recall #Z-1452-2026
Open, ClassifiedPosted Feb 20, 2026·Initiated Nov 11, 2025
Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: ResectoscopeDistribution: US Nationwide Distribution.Recall #Z-1453-2026
Open, ClassifiedPosted Feb 20, 2026·Initiated Nov 11, 2025
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Endoscope, Ac-Powered And AccessoriesDistribution: US Nationwide Distribution.Recall #Z-1454-2026
Open, ClassifiedPosted Feb 20, 2026·Initiated Nov 11, 2025
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: ResectoscopeDistribution: US Nationwide Distribution.Recall #Z-1455-2026
Open, ClassifiedPosted Feb 20, 2026·Initiated Nov 11, 2025
Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: ResectoscopeDistribution: US Nationwide Distribution.Recall #Z-1456-2026
Open, ClassifiedPosted Feb 20, 2026·Initiated Nov 11, 2025
Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.
Reason: Complaints of the ceramic tip of the resection sheath breaking have been received.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: ResectoscopeDistribution: US Nationwide Distribution.Recall #Z-1457-2026
Open, ClassifiedPosted Feb 18, 2026·Initiated Jan 16, 2026
Olympus 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.
Reason: Issue with software algorithm which may lead to overpressure events.
Root cause: Software design
Recalling firm: Olympus Corporation of the AmericasType: Insufflator, LaparoscopicDistribution: Nationwide distributionRecall #Z-1352-2026
Open, ClassifiedPosted Feb 18, 2026·Initiated Jan 16, 2026
Olympus 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.
Reason: Issue with software algorithm which may lead to overpressure events.
Root cause: Software design
Recalling firm: Olympus Corporation of the AmericasType: Insufflator, LaparoscopicDistribution: Nationwide distributionRecall #Z-1353-2026
Open, ClassifiedPosted Feb 18, 2026·Initiated Jan 16, 2026
Olympus 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.
Reason: Issue with software algorithm which may lead to overpressure events.
Root cause: Software design
Recalling firm: Olympus Corporation of the AmericasType: Insufflator, LaparoscopicDistribution: Nationwide distributionRecall #Z-1354-2026
Open, ClassifiedPosted Feb 18, 2026·Initiated Nov 17, 2025
Da Vinci 5
ASSY, DV5 CONSOLE, IS5000
Model/Catalog Number: 380730
Used for minimally invasive surgery.
Reason: An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.
Root cause: Software Design Change
Recalling firm: Intuitive Surgical, Inc.Type: System, Surgical, Computer Controlled InstrumentDistribution: US distribution: LA, MA, NY, PA, TX, and VA.Recall #Z-1428-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1371-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1372-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1373-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1374-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1375-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1376-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1377-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1378-2026
Open, ClassifiedPosted Feb 17, 2026·Initiated Oct 22, 2025
Olympus Thunderbeat, 5 mm, 45 cm Inline Grip
Reason: Firm is initiating a removal due to continued reports of adverse events.
Root cause: Under Investigation by firm
Recalling firm: Olympus Corporation of the AmericasType: Instrument, Ultrasonic SurgicalDistribution: Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Germany, Mexico, and Japan.Recall #Z-1379-2026