Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers

October 20, 2026The U.S. Food and Drug Administration (FDA) is alerting health care providers about an import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries. Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus.

Therefore, the FDA has issued an import alert to prevent future shipments of certain devices from entering the United States, including specific models of: Ureterorenoscopes, which are used to perform various diagnostic and therapeutic procedures within the urinary tract,Bronchoscopes, which are used to perform various diagnostic and therapeutic procedures in the respiratory tract, Laparoscopes, which are used to perform various diagnostic and therapeutic procedures in the abdomen and pelvis, Automated endoscope reprocessors, which are used to reprocess various endoscopes,Ingestible telemetric gastrointestinal capsule imaging systems, which are used for visualization of the small bowel mucosa, andEnteroscopes, which are used to provide visualization and perform procedures within the small intestine.Recommendations for Health Care ProvidersThe FDA recommends that health care providers:Be aware of the FDA import alert for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus), under which the devices will be refused entry into the U.S.: Import Alert 89-04 for failure to meet quality system regulation requirements.Refer to the table below for model numbers and Unique Device Identifiers (UDI) for the devices included in the import alert.Be aware that the import alert does not apply to related products (such as replacement parts, connectors, or single use consumables) used with the devices subject to import alert. If devices subject to the import alert are currently in use, users may continue using them if they are not experiencing any problems with the devices.Follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components.Do not use damaged devices or those that have failed a leak test, as they could be a potential source of contamination.Develop schedules for routine inspection and periodic maintenance in accordance with manufacturer’s instructions.Be aware that some devices under this import alert may have been recalled. If devices subject to the import alert were recalled, users should follow the firm’s recall customer notification letter, which should provide specific product instructions identified by the firm.Discuss the benefits and risks associated with procedures involving these devices with your patients.

The FDA does not recommend that procedures be canceled or delayed without discussion of the benefits and risks between the health care provider and patient.Complete prompt reporting of adverse events to help the FDA identify and better understand the risks associated with these devices.BackgroundThe FDA has issued warning letters and import alerts regarding current good manufacturing practice (CGMP) requirements and various reporting requirements, including recalls that the FDA identified as the most serious type of recall.FDA ActionsThe FDA has taken several actions related to quality system requirements and compliance concerns with Olympus. The FDA monitors corrective actions related to ongoing device quality violations. The FDA takes seriously its role in ensuring that medical devices are safe and effective.The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.Unique Device IdentifierThe FDA established the unique device identification system (UDI) to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceList of Olympus Devices Subject to Import AlertDevice NameVersion or ModelDevice Identifier (DI) NumberEffective June 24, 2025BronchofiberscopeBF-PE204953170062988; 04953170339974BronchofiberscopeBF-TE204953170063008BronchovideoscopeBF-1T15004953170288968BronchovideoscopeBF-1TQ17004953170342943BronchovideoscopeBF-P15004953170288876; 04953170308178BronchovideoscopeBF-Q17004953170342912Endoeye Flex 3D Deflectable VideoscopeLTF-190-10-3D04953170434938Endoeye Flex Deflectable VideoscopeLTF-S190-504953170310355Endoscope ReprocessorOER-PRO04953170258589Endoscope ReprocessorOER-MINI04953170331619Endoscope ReprocessorOER-Elite04953170404047Endoscope ReprocessorOER-AWNot AvailableEvis Exera BronchofibervideoscopeBF-MP160F04953170289064Evis Exera BronchofibervideoscopeBF-XP160F04953170340116Evis Exera BronchovideoscopeBF-3C16004953170340031Evis Exera BronchovideoscopeBF-XT16004953170340147Evis Exera II BronchovideoscopeBF-1T18004953170339325Evis Exera II BronchovideoscopeBF-1TQ18004953170339349Evis Exera II BronchovideoscopeBF-P18004953170339288Evis Exera II BronchovideoscopeBF-Q18004953170339301Evis Exera II BronchovideoscopeBF-Q180-AC04953170340086Evis Exera III BronchofibervideoscopeBF-MP190F04953170395581Evis Exera III BronchovideoscopeBF-P19004953170434983Evis Exera III BronchovideoscopeBF-XP19004953170342134Evis Exera PleuravideoscopeLTF-16004953170340284HD Endoeye Laparo-Thoraco VideoscopeLTF-VH04953170287015LaparoscopeLTF-V3Not AvailableLaparoscopeLTF-VPNot AvailableLaparoscopeLTF-VP-SNot AvailableOES Bronchofiberscope Olympus BF Type N20BF-N2004953170442667OES BronchofiberscopeBF-1T6004953170339264OES BronchofiberscopeBF-3C4004953170339219OES BronchofiberscopeBF-MP6004953170308277OES BronchofiberscopeBF-P6004953170339196OES BronchofiberscopeBF-XP6004953170339240OES Uretero-Reno FiberscopeURF-P504953170340307Rhino-Laryngo FiberscopeENF-P404953170059032Rhino-Laryngo VideoscopeENF-V404953170411380Rhino-Laryngo VideoscopeENF-VH204953170411427Rhino-Laryngo VideoscopeENF-V304953170411366Rhino-Laryngo VideoscopeENF-VH04953170411403Rhino-Laryngo VideoscopeENF-VQ04953170411441Rhino-Laryngo VideoscopeENF-VT204953170411472Rhino-LaryngofiberscopeENF-XP04953170059018Rhino-LaryngofiberscopeENF-GP04953170078231Rhino-LaryngofiberscopeENF-T304953170411526Tracheal Intubation FiberscopeLF-DP04953170340192; 04953170136856Tracheal Intubation FiberscopeLF-GP04953170061998Tracheal Intubation FiberscopeLF-TP04953170136825Uretero-reno fiberscopeURF-P704953170403811Uretero-Reno FiberscopeURF-P7R04953170403835Uretero-Reno VideoscopeURF-V204953170343582Uretero-Reno VideoscopeURF-V2R04953170343612Uretero-Reno VideoscopeURF-V304953170435119Uretero-Reno VideoscopeURF-V3R04953170403392Uretero-Reno VideoscopeURF-V04953170340321Visera Cysto-Nephro VideoscopeENF-V204953170411342XENF-DP Rhino-LaryngofiberscopeENF-PGPNot AvailableEffective October 20, 2026Endocapsule Small Intestinal Capsule Endoscope SetMAJ-202704953170328268Evis Exera II Small Intestinal VideoscopeSIF-Q18004953170339943Endoeye Flex Deflectable VideoscopeLTF-S190-1004953170310386;04953170434662BronchovideoscopeBF-1TH110004953170424199BronchovideoscopeBF-H110004953170424229Timeline of Communication UpdatesA timeline and summary of the FDA's previous communications related to this issue are provided below.DateActions10/20/2026The FDA updated the letter to health care providers to include certain enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems placed on import alert, broadening the scope of the letter to include devices manufactured at locations in Japan.06/24/2025The FDA issued a letter to health care providers alerting them to an import alert on ureterorenoscopes, bronchoscopes, laparoscopes, and automated endoscope reprocessors manufactured by Olympus and its subsidiaries in Japan.Reporting Problems to the FDAThe FDA encourages health care providers to report any adverse events or suspected adverse events experienced with medical devices manufactured by Olympus:You can submit voluntary reports through MedWatch, the FDA Safety Information and Adverse Event Reporting program.Device manufacturers and user facilities must comply with the applicable Medical Device Reporting (MDR) regulations.Health care personnel employed by facilities that are subject to the FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.By promptly reporting adverse events, you can help the FDA identify and better understand the risks associated with medical devices.Contact InformationIf you have questions about this letter, contact the Office of Industry and Consumer Education (OICE).Additional ResourcesImport Alert 89-04 [10/19/2026]FDA Issues Two Warning Letters to Leading Manufacturer of Endoscopes [01/10/2023]Warning LettersOlympus Medical Systems Corporation Warning Letter [10/07/2026] Olympus Medical Systems Corporation Warning Letter (Hinode) [03/15/2023]Olympus Medical Systems Corporation Warning Letter (Hachioji-shi) [12/12/2022]Aizu Olympus Warning Letter [11/02/2022]Infections Associated with Reprocessed Duodenoscopes [06/30/2022]Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers [04/01/2021]