Source: US Department of Health and Human Services – 3
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:
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).
Additional Resources
Content current as of:
06/24/2025
Regulated Product(s)