Import Alerts for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers

June 24, 2025

The U.S. Food and Drug Administration (FDA) is alerting health care providers about import alerts 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, FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus. Therefore, the FDA has issued import alerts 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

Recommendations

The FDA recommends that health care providers:

Be aware of the FDA import alerts for certain medical devices manufactured in Japan by Olympus Medical Systems Corporation (Olympus) and its subsidiaries, under which the devices will be refused entry into the U.S.:
- Import Alert 89-04 for failure to meet quality system regulation requirements at Aizu, an Olympus manufacturing site in Japan
Refer to the table below for model numbers and Unique Device Identifiers (UDI) for the devices included in the import alerts.
- 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 you are currently using devices subject to the import alert, you may continue using these devices if you 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.
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 us identify and better understand the risks associated with these devices.

Background

The FDA has issued warning letters and import alerts where the FDA has determined that certain facilities were not in compliance with current good manufacturing practice (CGMP) requirements and various reporting requirements, including for recalls that the FDA identified as the most serious type of recall.

FDA Actions

The FDA has taken several actions related to quality system requirements and compliance concerns with Olympus.

The FDA is continuing to engage with Olympus to accelerate corrective actions related to ongoing violations and minimize risk to patients, and may take further action as appropriate. FDA takes seriously its role in assuring patients 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 Identifier

The 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.

List of Olympus Devices Subject to Import Alert

Device Name	Version or Model	Device Identifier (DI) Number
Bronchofiberscope	BF-PE2	04953170062988; 04953170339974
Bronchofiberscope	BF-TE2	04953170063008
Bronchovideoscope	BF-1T150	04953170288968
Bronchovideoscope	BF-1TQ170	04953170342943
Bronchovideoscope	BF-P150	04953170288876; 04953170308178
Bronchovideoscope	BF-Q170	04953170342912
Endoeye Flex 3D Deflectable Videoscope	LTF-190-10-3D	04953170434938
Endoeye Flex Deflectable Videoscope	LTF-S190-5	04953170310355
Endoscope Reprocessor	OER-PRO	04953170258589
Endoscope Reprocessor	OER-MINI	04953170331619
Endoscope Reprocessor	OER-Elite	04953170404047
Endoscope Reprocessor	OER-AW	Not Available
Evis Exera Bronchofibervideoscope	BF-MP160F	04953170289064
Evis Exera Bronchofibervideoscope	BF-XP160F	04953170340116
Evis Exera Bronchovideoscope	BF-3C160	04953170340031
Evis Exera Bronchovideoscope	BF-XT160	04953170340147
Evis Exera II Bronchovideoscope	BF-1T180	04953170339325
Evis Exera II Bronchovideoscope	BF-1TQ180	04953170339349
Evis Exera II Bronchovideoscope	BF-P180	04953170339288
Evis Exera II Bronchovideoscope	BF-Q180	04953170339301
Evis Exera II Bronchovideoscope	BF-Q180-AC	04953170340086
Evis Exera III Bronchofibervideoscope	BF-MP190F	04953170395581
Evis Exera III Bronchovideoscope	BF-P190	04953170434983
Evis Exera III Bronchovideoscope	BF-XP190	04953170342134
Evis Exera Pleuravideoscope	LTF-160	04953170340284
HD Endoeye Laparo-Thoraco Videoscope	LTF-VH	04953170287015
Laparoscope	LTF-V3	Not Available
Laparoscope	LTF-VP	Not Available
Laparoscope	LTF-VP-S	Not Available
OES Bronchofiberscope Olympus BF Type N20	BF-N20	04953170442667
OES Bronchofiberscope	BF-1T60	04953170339264
OES Bronchofiberscope	BF-3C40	04953170339219
OES Bronchofiberscope	BF-MP60	04953170308277
OES Bronchofiberscope	BF-P60	04953170339196
OES Bronchofiberscope	BF-XP60	04953170339240
OES Uretero-Reno Fiberscope	URF-P5	04953170340307
Rhino-Laryngo Fiberscope	ENF-P4	04953170059032
Rhino-Laryngo Videoscope	ENF-V4	04953170411380
Rhino-Laryngo Videoscope	ENF-VH2	04953170411427
Rhino-Laryngo Videoscope	ENF-V3	04953170411366
Rhino-Laryngo Videoscope	ENF-VH	04953170411403
Rhino-Laryngo Videoscope	ENF-VQ	04953170411441
Rhino-Laryngo Videoscope	ENF-VT2	04953170411472
Rhino-Laryngofiberscope	ENF-XP	04953170059018
Rhino-Laryngofiberscope	ENF-GP	04953170078231
Rhino-Laryngofiberscope	ENF-T3	04953170411526
Tracheal Intubation Fiberscope	LF-DP	04953170340192; 04953170136856
Tracheal Intubation Fiberscope	LF-GP	04953170061998
Tracheal Intubation Fiberscope	LF-TP	04953170136825
Uretero-reno fiberscope	URF-P7	04953170403811
Uretero-Reno Fiberscope	URF-P7R	04953170403835
Uretero-Reno Videoscope	URF-V2	04953170343582
Uretero-Reno Videoscope	URF-V2R	04953170343612
Uretero-Reno Videoscope	URF-V3	04953170435119
Uretero-Reno Videoscope	URF-V3R	04953170403392
Uretero-Reno Videoscope	URF-V	04953170340321
Visera Cysto-Nephro Videoscope	ENF-V2	04953170411342
XENF-DP Rhino-Laryngofiberscope	ENF-PGP	Not Available

Reporting Problems to the FDA

The 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 Information

If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE).