October 2026: FDA Expands Endoscope Import Alert—Olympus Japan-Made Enteroscopes and Capsule Endoscopes Detained on Arrival

October 2026 FDA Expansion of Endoscope Import Alert: Olympus Japan-Made Enteroscopes and Capsule Endoscopes Detained on Arrival

Published: October 29, 2026, 09:51 | Category: Registration and Market Access

A Letter and a List

On October 20, 2026, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) updated a public letter to health care providers concerning certain medical devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries that are subject to an import alert. The letter states directly that, although FDA and the company have continued to address compliance issues, the company’s violations of the Quality System Regulation have not been resolved; FDA therefore issued the import alert to prevent subsequent shipments of the affected devices from entering the United States. The associated Import Alert No. 89-04 is dated October 19, 2026, and is of the Detention Without Physical Examination (DWPE) type.

This is not an isolated letter. It updates the public letter of June 24, 2025, and the actions along the same line have continued for more than a year.

Two Changes in Scope: Two Additional Categories and Additional Locations

The letter names six device categories: ureteroscopes, bronchoscopes, laparoscopes, endoscope reprocessors (automated cleaning and disinfection machines), ingestible telemetric gastrointestinal capsule imaging systems, and enteroscopes. Compared with the initial June 2025 version, which covered four categories—ureteroscopes, bronchoscopes, laparoscopes, and endoscope reprocessors—the update makes two substantive changes. First, enteroscopes and capsule imaging systems are added, bringing small-bowel examination and treatment into the listed scope. Second, the timeline in the public letter states that the scope has also expanded to devices manufactured at multiple locations in Japan, rather than the previously stated scope.

The public letter includes a list grouped by effective date. There are 58 model entries effective June 24, 2025, and 5 entries effective October 20, 2026: the Endocapsule small-bowel capsule endoscope set MAJ-2027, the Evis Exera II small-bowel enteroscope SIF-Q180, the Endoeye Flex flexible video endoscope LTF-S190-10, and the bronchoscopes BF-1TH1100 and BF-H1100. Each entry provides the model and device identifier (DI); for some models, the DI field states “Not Available.” In addition to the six categories named in the letter, the table also includes models such as nasopharyngoscopes and fiberoptic intubation scopes.

Boundary: New Shipments, Not Devices Already in Use

The public letter defines the scope of application specifically. The import alert does not apply to accessories for the affected devices, such as replacement parts, connectors, and single-use consumables. Devices already in use may continue to be used if no problems occur during use. Damaged devices or devices that fail leak testing must not be used. Cleaning and reprocessing must be performed in accordance with the labeling and instructions for use, and routine inspection and periodic maintenance must be scheduled as required by the manufacturer.

For hospitals, the most important statement is this: FDA does not recommend canceling or postponing procedures without discussing benefits and risks with the patient. In other words, the focus of handling is on the supply chain and reprocessing, not on stopping procedures in the operating room.

Enforcement Basis: Refusal of Admission and “Adulteration”

The title of Import Alert 89-04 is “Detention Without Physical Examination of Devices from Manufacturers Who Have Not Met Device Quality System Requirements.” The basis section states that shipments may be refused admission under Section 801(a)(1) of the Federal Food, Drug, and Cosmetic Act because the methods or facilities used for their manufacture, packing, storage, or installation do not conform to the requirements of Section 520(f)(1), or do not conform to conditions in an order under Section 520(f)(2), corresponding to the adulteration provisions of Section 501(h). The detention code in the system is DEVICEGMPS.

To be removed from the Red List, a company must submit information to FDA sufficient to demonstrate that the issues have been resolved, or submit an application in accordance with the procedures. Until then, detention is the norm.

Another Document at the Same Time

On October 7, 2026, FDA issued a Warning Letter (CMS #729208) to Olympus Medical Systems Corporation. The letter records inspections of six facilities in November 2025: Hachioji, Aomori, Hinode, and Shirakawa in Japan; Hamburg in Germany; and Brooklyn Park, Minnesota, in the United States. The conclusion was that devices manufactured at these facilities did not conform to the Quality System requirements of 21 CFR Part 820 and were therefore adulterated under Section 501(h).

The examples in the letter are specific. For the UHI-4 insufflation unit at the Shirakawa facility, the risk management report did not reflect known catastrophic hazards such as air embolism, arrhythmia, and patient death, and design validation did not simulate actual use conditions such as pressure sensor failure or inaccurate pressure readings. For the sphincterotome at the Aomori facility, the risk report described the consequence of complaints only as “delayed treatment,” omitting bleeding from inadvertent vascular incision already reported in Medical Device Reports. The company submitted multiple rounds of responses between December 2025 and July 2026, but FDA considered the evidence still insufficient.

Viewed together, the import alert is not a one-time enforcement action; it is the result of quality system issues being applied at the trade and import stage.

What the Public Letter Does Not Say

The letter does not provide inventory quantities for the affected models, does not state when the company will be able to remediate to the point of removing the detention, and does not provide a safety conclusion for any specific model. FDA states that it will continue to communicate new or supplemental information to health care providers and the public. The list itself may also change as official pages are updated; when verifying, the page as of that day should be authoritative.

Sources and Scope of Application

Sources: U.S. Food and Drug Administration (CDRH), Update: Import Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers, October 20, 2026, https://www.fda.gov/medical-devices/letters-health-care-providers/update-import-alert-certain-olympus-medical-devices-manufactured-japan-letter-health-care-providers; U.S. Food and Drug Administration, Import Alert 89-04, issued October 19, 2026, https://www.accessdata.fda.gov/cms_ia/importalert_241.html; U.S. Food and Drug Administration, Warning Letter to Olympus Medical Systems Corporation (CMS #729208), October 7, 2026, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/olympus-medical-systems-corporation-729208-10072026.

Verification scope and access date: This article verified the three official pages above, comparing item by item the model list grouped by effective date in the public letter (58 entries corresponding to June 24, 2025, and 5 entries corresponding to October 20, 2026), the timeline records, and the enforcement basis of the import alert; it also checked the CDRH New page entry dated October 20, 2026 to confirm the publication date. The access date was October 29, 2026.

Scope note: This article is an interpretation of public regulatory information and does not constitute a conclusion or commitment regarding any specific product, company, or registration application. The import alert is U.S. enforcement guidance at the point of entry; its terms, list, and implementation are subject to the official text and may change with subsequent official updates.

Information Sources

• U.S. Food and Drug Administration (CDRH), 2026-10-20
• U.S. Food and Drug Administration, 2026-10-19
• U.S. Food and Drug Administration, 2026-10-07

AIMEILI Regulatory Interpretation and Business Impact

Regulatory interpretation. Import Alert 89-04 is a DWPE import alert, not a field safety notice or recall. Its immediate legal effect is at the U.S. border: new shipments of the listed Olympus Japan-made devices may be detained without physical examination. The alert does not, by itself, require hospitals to stop using devices already in service, and FDA’s health care provider letter advises against canceling or postponing procedures without a patient-specific benefit-risk discussion.

• The scope is shipment-specific and model-specific. Regulatory teams should verify each model and DI against the current Import Alert 89-04 list, including the 58 entries effective June 24, 2025, and the 5 entries effective October 20, 2026. The newly listed models include MAJ-2027, SIF-Q180, LTF-S190-10, BF-1TH1100, and BF-H1100.
• Accessories and consumables are outside the alert’s stated scope. Replacement parts, connectors, and single-use consumables are not covered by the import alert according to the public letter. This distinction is important for inventory planning and customer communications.
• The root cause is unresolved quality system compliance. The October 7, 2026 Warning Letter cites nonconformity with 21 CFR Part 820 and adulteration under Section 501(h), with specific findings on risk management and design validation. Import Alert 89-04 should therefore be understood as an enforcement consequence of unresolved quality system issues, not merely a customs documentation problem.
• Removal from the Red List requires evidence. A firm must submit sufficient information to FDA demonstrating that the underlying issues have been resolved or follow the applicable application process. Until FDA removes the firm or products from the Red List, detention without physical examination remains the default for affected shipments.

Business impact for global manufacturers, distributors, CROs, and regulatory affairs teams.

• Supply continuity in the U.S. market. U.S. hospitals and distributors may face constrained availability of the affected Olympus Japan-made enteroscopes and capsule endoscopes. Distributors should review inventory, backorders, allocation policies, and alternative sourcing options while maintaining clear communication with clinical customers.
• Import and customs operations. Importers and customs brokers should screen entries against the current list before shipment and anticipate possible detention without physical examination. Entry documentation, model and DI identification, country-of-origin information, and contingency plans for refused admission should be reviewed in advance.
• Clinical and postmarket handling. Health care facilities should not automatically remove in-use devices solely because of the import alert. They should follow labeling and instructions for use, perform required leak testing, maintain reprocessing and maintenance schedules, and report adverse events or device malfunctions as required. Clinical decisions about canceling or delaying procedures should be made through a patient-specific benefit-risk discussion.
• Quality remediation and regulatory strategy. Manufacturers with comparable quality system exposure should review risk management files, design verification and validation, complaint handling, Medical Device Reporting, supplier controls, and facility oversight. Remediation evidence should be sufficiently robust to support interactions with FDA and, where applicable, removal from import alert status.
• CRO and consultancy support. Regulatory affairs teams and service providers may need to support gap assessments against 21 CFR Part 820, risk management remediation, design validation documentation, complaint and MDR review, import alert response strategy, and communication with U.S. distributors and clinical customers.

Practical next steps. Confirm whether any affected model or DI is in current inventory or in transit; map country of origin and shipment status; prepare customer-facing statements that distinguish new shipment detention from in-use device status; reinforce reprocessing, leak testing, and maintenance instructions; and monitor FDA official pages for updates to Import Alert 89-04, the health care provider letter, and the Warning Letter follow-up.