Provider notice adds five model entries
FDA updated its Olympus provider letter on October 20, 2026, expanding its coverage to enteroscopes and capsule gastrointestinal imaging systems manufactured in Japan. The table places five models under an October 20 effective-date heading:
- MAJ-2027: Endocapsule Small Intestinal Capsule Endoscope Set.
- SIF-Q180: Evis Exera II Small Intestinal Videoscope.
- LTF-S190-10: Endoeye Flex Deflectable Videoscope.
- BF-1TH1100 and BF-H1100: bronchovideoscopes.
FDA attributes the action to unresolved quality-system violations. This is import enforcement, not a new law or a recall of every listed unit. Provider letter
Import restrictions remain product- and facility-specific
Import Alert 89-04 was updated on October 19. It permits detention without physical examination of listed products from listed manufacturers. Relevant Olympus entries identify capital equipment; they do not establish a blanket ban on all Olympus products.
The dates require care: BF-1TH1100 and BF-H1100 also appear in an Aizu Olympus entry dated June 24, 2025. The October 20 grouping in the provider letter should therefore not be read as the first restriction on those models from every manufacturing site. Import Alert 89-04
FDA’s October 7 warning letter supplies the broader compliance context. It describes inspection findings involving design controls and other quality-system requirements at multiple facilities. Those findings are FDA’s stated conclusions; the warning letter’s wider scope should not be substituted for the import alert’s specific product listings. Warning letter
Existing equipment and related supplies
FDA says providers may continue using affected devices already in service if they are experiencing no problems, while following labeling, reprocessing and maintenance instructions. Damaged devices and devices that fail leak testing should not be used. Any separate recall instructions still apply.
The provider letter excludes related replacement parts, connectors and single-use consumables from this import alert. It also advises against canceling or delaying procedures without discussing benefits and risks with patients. Provider recommendations
Sources
- Primary official sourceImport Alert for Certain Olympus Medical Devices Manufactured in Japan - Letter to Health Care Providers (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceImport Alert 89-04 (opens in a new tab)U.S. Food and Drug Administration
- Supporting sourceOlympus Medical Systems Corporation - MARCS-CMS 729208 - October 07, 2026 (opens in a new tab)U.S. Food and Drug Administration