On October 20, 2026, the U.S. Food and Drug Administration published a letter to health care providers: certain devices manufactured in Japan by Olympus Medical Systems Corporation and its subsidiaries will be refused entry into the United States under Import Alert 89-04 for failure to meet quality system regulation requirements. The October 20, 2026 update includes certain enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems and broadens the letter to devices manufactured at locations in Japan. LTF-S190-10, BF-1TH1100 and BF-H1100 are additional scope models. MAJ-2027 is the capsule set. SIF-Q180 is the enteroscope. US importers and distributors of the listed Olympus devices must immediately check incoming shipments against the letter's model and unique device identifier list before the next US entry, or devices on Import Alert 89-04 are refused entry.
US health care providers, hospital buyers and user facilities that use those devices follow the letter: continue use only if there is no problem, follow labeling and reprocessing, do not use a damaged device or a failed leak test, and follow a recall letter when one exists. The alert does not apply to replacement parts, connectors, or single use consumables.
- Authority : U.S. Food and Drug Administration
- Entity : Olympus Medical Systems Corporation and its subsidiaries
- Measure and amount : import alert, future shipments refused entry into the United States, no fine stated
- Legal basis : Import Alert 89-04 for failure to meet quality system regulation requirements
- Decision date : letter dated October 20, 2026
- Official source : FDA letter to health care providers, October 20, 2026
What happened
FDA wrote that outstanding Quality System regulation violations remain, so future shipments of the listed devices are stopped. The June 24, 2025 table covers ureterorenoscopes, bronchoscopes, laparoscopes, automated endoscope reprocessors, and the rhino-laryngoscopes and intubation fiberscopes in that table. Rows effective October 20, 2026 are MAJ-2027 04953170328268, SIF-Q180 04953170339943, LTF-S190-10 04953170310386 and 04953170434662, BF-1TH1100 04953170424199, and BF-H1100 04953170424229. An Olympus warning letter dated October 7, 2026, listed under Additional Resources, is an earlier measure. October 19, 2026 appears only as the date label on the Import Alert 89-04 link there, not as a row date.
The breach
The letter's ground is Import Alert 89-04 for failure to meet quality system regulation requirements. It names outstanding Quality System regulation violations, quotes no 21 CFR Part 820 subsection, and states no fine. Import Alert 89-04 is the alert named in the recommendations.
Who else is in the same regime
The letter addresses US importers and distributors of the listed Olympus devices, and US health care providers, hospital buyers and user facilities that use those devices. It tells providers to continue use only if there is no problem, follow labeling and reprocessing, not use a damaged device or a failed leak test, follow a recall letter when one exists, and discuss benefits and risks before canceling a procedure. It names no other manufacturer.
What to check now
- Match incoming shipments to the June 24, 2025 and October 20, 2026 model and device-identifier rows, including MAJ-2027, SIF-Q180, LTF-S190-10, BF-1TH1100 and BF-H1100, before the next US entry.
- Leave replacement parts, connectors and single use consumables outside the alert.
- For a device in use, confirm there is no problem, follow labeling and reprocessing, and do not use a damaged device or a failed leak test.
- Follow a recall customer notification letter when one exists, and discuss benefits and risks before canceling a procedure.
- Report adverse events as the letter describes, including Medical Device Reporting for manufacturers and user facilities.
