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The FDA has issued Import Alert 89-04 for specified medical devices made in Japan by Olympus Medical Systems Corporation and its subsidiaries, citing outstanding quality-system violations. The alert blocks covered devices from future U.S. entry; the FDA says it does not apply to related parts or single-use supplies, and says devices already in use may remain in use if they are not experiencing problems.
The U.S. Food and Drug Administration said on October 20, 2026, that certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries are subject to an import alert and will be refused entry to the United States. The FDA cited outstanding Quality System regulation violations, a move affecting specified scopes, reprocessors and other devices used in diagnostic and treatment procedures.
The alert is Import Alert 89-04, which the FDA describes as applying to certain Olympus devices for failure to meet quality-system requirements. The agency says its concerns remain despite Olympus’s “extensive and ongoing efforts” to address compliance issues. The alert prevents future shipments of the covered devices from entering the U.S.; the supplied FDA notice does not say that all Olympus products are affected.
The listed device categories include ureterorenoscopes, bronchoscopes, laparoscopes, automated endoscope reprocessors, ingestible telemetric gastrointestinal capsule imaging systems and enteroscopes. The FDA provides model numbers and device identifier numbers, or DIs, to help providers identify covered products. The notice’s supplied list includes, among others, several Evis Exera bronchoscopes, Endoeye videoscopes and OER-series endoscope reprocessors. Providers should check the agency’s full list and product labels rather than relying on the category name alone.
The FDA says the alert does not cover associated products such as replacement parts, connectors or single-use consumables used with affected devices. It also says providers may continue using a covered device already in service if it is not experiencing problems. That advice is not a blanket assurance about every unit: the agency separately tells providers not to use damaged devices or devices that have failed a leak test, and to follow cleaning, reprocessing, inspection and maintenance instructions.
How the Alert Affects U.S. Hospitals
The import alert can affect future supply and purchasing of the specified models in the United States, including equipment used for procedures involving the urinary tract, lungs, abdomen and pelvis, and small intestine. Facilities that use listed devices may need to verify model and UDI information, review their available inventory and consider whether alternative equipment is needed for future procedures. The FDA notice does not quantify how many devices or facilities are affected.
For patients, the FDA does not recommend canceling or delaying procedures automatically. It advises clinicians to discuss the benefits and risks of procedures involving these devices with patients. This leaves decisions about an individual procedure to the care team and patient, based on the device’s condition and clinical circumstances. The alert concerns regulatory compliance and importation; it does not, on its own, establish that every listed device currently in use has malfunctioned or caused harm.
The agency also asks providers to report adverse events promptly. Such reports can help the FDA identify and better understand potential risks. Providers should check whether a particular unit is subject to a separate recall and, if so, follow the manufacturer’s recall notification for that product.
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Prior FDA Compliance Actions
The October 20 letter places the import alert within a broader history of FDA action involving Olympus quality-system and reporting requirements. The agency says it has issued warning letters and import alerts relating to current good manufacturing practice requirements and various reporting obligations, including recall reporting. The notice describes certain recalls identified by the FDA as its most serious type of recall, but it does not identify those recalls in the supplied material as applying to every device on the current import-alert list.
The FDA says it continues to monitor Olympus’s corrective actions related to ongoing device-quality violations. It also explains that its unique device identification system is intended to identify medical devices sold in the United States from manufacture through distribution and patient use. The agency directs users to the model and DI list and to AccessGUDID, its database for identifying devices. The notice states that the listed import alert was effective June 24, 2025, while the provider letter informing readers of the alert is dated October 20, 2026.
“Despite extensive and ongoing efforts to address compliance issues, the FDA continues to have concerns related to outstanding Quality System regulation violations by Olympus.”
— U.S. Food and Drug Administration
Scope and Device-Specific Status
The notice establishes that specified models are covered, but the supplied source excerpt does not provide a complete, reliably readable model-and-DI table: its final entry is truncated. The full FDA list is needed to establish whether a specific model or device identifier is included. The notice also does not state the number of units affected, the size of existing U.S. inventories, or how long the import restriction may remain in place.
The FDA’s announcement does not detail each outstanding quality-system violation, describe the corrective actions Olympus has taken, or identify a finding that every covered device is defective. It also does not say that all devices already in use must be removed. Whether any specific unit is subject to a recall must be checked separately against the manufacturer’s notice and applicable FDA information.
Provider Checks and FDA Updates
Health care providers should compare the model and UDI on each device with the FDA’s full Import Alert 89-04 list and consult AccessGUDID when they need to identify a product. They should follow the device labeling and reprocessing instructions, keep routine inspection and maintenance schedules, and stop using a device that is damaged or has failed a leak test. If a listed device was recalled, the FDA says users should follow the firm’s customer notification letter for product-specific instructions.
The FDA says it is monitoring Olympus’s corrective actions and will share additional information if it becomes available. The notice does not set out a date for lifting or revising the alert. Providers and patients should discuss the risks and benefits of a planned procedure with the treating clinician rather than assume that the alert requires a procedure to be canceled or delayed.
Key Questions
Which Olympus products are covered by the import alert?
The alert covers specified models in categories including bronchoscopes, ureterorenoscopes, laparoscopes, endoscope reprocessors, gastrointestinal capsule imaging systems and enteroscopes. Check the FDA’s full model and DI list; not every Olympus product is identified as covered.
Can a hospital keep using an affected device it already has?
The FDA says a covered device already in use may continue to be used if it is not experiencing problems. Do not use damaged equipment or a device that has failed a leak test, and follow the manufacturer’s instructions and any recall notice.
Does the import alert cover replacement parts or single-use supplies?
No. The FDA says the alert does not apply to related products such as replacement parts, connectors or single-use consumables used with devices subject to the alert.
Does the FDA advise canceling procedures that use these devices?
The FDA does not recommend automatic cancellation or delay. It advises clinicians and patients to discuss the benefits and risks of the procedure in light of the specific device and clinical circumstances.
Why did the FDA issue the alert?
The agency says it continues to have concerns about outstanding Quality System regulation violations despite Olympus’s efforts to address compliance issues. The alert prevents future shipments of the specified devices from entering the United States.
Source: primary
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