FDA adds Olympus enteroscopes and capsule systems to Import Alert 89-04

MedDevice Startups Staff · 1 day ago · 2 min read · Via FDA letter to health care providers

FDA expanded Import Alert 89-04 on October 20 to cover more Olympus devices made in Japan. The additions are the Endocapsule small intestinal capsule set (MAJ-2027), the Evis Exera II small intestinal videoscope (SIF-Q180), the Endoeye Flex videoscope (LTF-S190-10), and two bronchovideoscopes, the BF-1TH1100 and the BF-H1100.

The alert covers failure to meet quality system regulation requirements. It first hit Olympus on June 24, 2025, across ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors. FDA says it still has concerns about outstanding quality system violations despite extensive and ongoing company efforts. Olympus took a warning letter dated October 7, 2026.

FDA told providers that devices already in use may stay in use if they show no problems, and to keep to the labeling and reprocessing instructions. Replacement parts, connectors and single-use consumables are not covered. An import alert squeezes new supply rather than the installed base, so the pressure lands on sites waiting on scope orders.

Questions & Answers

Which Olympus devices were added to FDA Import Alert 89-04 in October 2026?

On October 20, 2026, FDA added the Olympus Endocapsule small intestinal capsule set (MAJ-2027), the Evis Exera II small intestinal videoscope (SIF-Q180), the Endoeye Flex videoscope (LTF-S190-10), and the BF-1TH1100 and BF-H1100 bronchovideoscopes.

Why is Olympus subject to FDA Import Alert 89-04?

Import Alert 89-04 covers failure to meet quality system regulation requirements. FDA says it continues to have concerns about outstanding quality system violations at Olympus Medical Systems in Japan, despite ongoing remediation.

Can hospitals keep using Olympus scopes covered by the import alert?

Yes. FDA told providers that Olympus devices already in use may continue in use if they show no problems, and advised following labeling, reprocessing and leak-test instructions.

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