Olympus Corporation of the Americas

111 FDA enforcement actions

111 Total Recalls

27 Class I

84 Class II

0 Class III

Firm Details

Product Types: device
States: PA

All Recalls

Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk 01/07/2026 device

Devices which did not undergo thermoforming could deform and lose performance.
Class I: Dangerous 10/30/2025 device

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.
Class II: Risk 10/17/2025 device

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.
Class II: Risk 10/14/2025 device

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.
Class II: Risk 10/08/2025 device

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.
Class II: Risk 10/06/2025 device

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.
Class II: Risk 10/06/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 09/11/2025 device

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.
Class I: Dangerous 08/06/2025 device

Potential for undetected, deformed a-traumatic tips.
Class II: Risk 07/25/2025 device

Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Class II: Risk 07/25/2025 device

Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 06/18/2025 device

Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Class II: Risk 05/06/2025 device

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II: Risk 05/06/2025 device

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II: Risk 05/06/2025 device

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II: Risk 05/06/2025 device

Potential for thermal incident including an unexpected occurrence of smoke, sparks, burning, or unsteady flames during clinical use. The fracturing of the fiber is the cause of, or contributes to, these thermal incidents.
Class II: Risk 05/05/2025 device

Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure.
Class II: Risk 04/04/2025 device

Preset treatment parameters are not consistently being used in accordance with the IFU.
Class I: Dangerous 01/15/2025 device

Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into the patient.
Class I: Dangerous 12/18/2024 device

Potential for inadvertent retention of biomaterial when the reprocessing procedure is not performed as instructed, so as not completely removing and disassembling the device.
Class II: Risk 12/16/2024 device

Potential for distal tip tearing of the Mechanical Lithotriptor V.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/25/2024 device

The probe tips of the hand instruments are being damaged or breaking including pad damage and detachment.
Class II: Risk 11/19/2024 device

Potential that Duravent Silicone Ventilation Tubes may contain incorrect product, specifically, 1.32 mm Tiny T Tubes (model: 70240076) instead of the intended Duravent Silicone Ventilation Tubes.
Class II: Risk 10/31/2024 device

High-level disinfection ("HLD") with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor ("AER") has been removed as a compatible reprocessing method from the Instructions for Use when reprocessing the GIF-1THI90 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE ( GIF-1TH190 ).
Class II: Risk 09/24/2024 device

Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-1-2. Electromagnetic interference occurring during a procedure may cause the device to malfunction requiring the replacement of the device. This could potentially result in a prolonged procedure and/or require additional medical intervention
Class II: Risk 09/18/2024 device

To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors evaluation of the GIF-1TH190.
Class II: Risk 09/13/2024 device

Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a damaged tip during use of a laser probe.
Class II: Risk 09/13/2024 device

Mislabeled Glo Cath Label (attached to the device) states: 11 mm, 12 mm, 13 mm however the balloon is 8.5mm, 9.5mm and 10.5 mm and may result in prolonged surgery. All other labeling is correct for the balloon, including the Shelf Box with Front Box Label and Circular Star Label and the balloon Pouch
Class II: Risk 09/11/2024 device

Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.
Class II: Risk 09/04/2024 device

There was an increase in complaints indicating an occurrence of system error E1226 "Could not write to Audio Buffer" during procedures using the ESG-410 (SEP).
Class II: Risk 08/23/2024 device

During product testing, Olympus identified an intermittent loss of function of the OFP-2 Flushing Pump caused by an internal component connection failure.
Class II: Risk 08/21/2024 device

It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore, specifications are not met.
Class II: Risk 08/13/2024 device

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Class II: Risk 08/13/2024 device

The term Bladder Stone was incorrectly translated in both Spanish and Portuguese to Kidney Stone(Clculo renal) on the systems Graphical User Interface (GUI), a potential to deliver an incorrect or unintended amount of energy to the patients anatomy.
Class II: Risk 07/01/2024 device

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Class II: Risk 07/01/2024 device

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Class II: Risk 07/01/2024 device

Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach
Class II: Risk 06/21/2024 device

Electrosurgical Generators ESG-410 does not power on upon use, may result in delays in initiating treatment or prolonged surgery
Class II: Risk 05/31/2024 device

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Class II: Risk 05/31/2024 device

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Class II: Risk 05/31/2024 device

Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Class II: Risk 04/24/2024 device

A subset of the ES4K systems do not have complete records for earth leakage testing. The earth leakage test is a series of measurements intended to confirm that the amount of electrical current flowing to the earth is within standard limits
Class II: Risk 04/18/2024 device

The required leakage test was not performed following of a re-work for a non-conformity. This could potentially result in liquid ingress into the eyepiece and cause a foggy image.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.