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Olympus gets FDA warning letter covering six sites, says no recall or production limit

Olympus says an FDA warning letter on quality-system findings at six facilities does not limit production or sales or require a recall, and that it will respond within 15 business days.

By Tokyo Brief DeskOct 13, 20262 min readOLYMPUS CORPORATION7733
A coiled endoscope on a manufacturing bench beside six identical inspection tags, one marked with a small vermillion accent.

Olympus said it received a warning letter from the US Food and Drug Administration dated October 7, 2026, US time, following FDA inspections of its facilities in the second half of 2025. The company disclosed the letter in a notice dated October 13.

Six sites, one quality-system question

The letter covers six facilities, according to Olympus: Olympus Medical Systems at Hachioji and Hinode, Aomori Olympus, Shirakawa Olympus, Olympus Winter & IBE GmbH in Hamburg, Germany, and Gyrus ACMI, Inc. in Brooklyn Park, US.

Olympus said the letter addresses the adequacy of its comprehensive response to matters on quality management systems and processes that were raised in a Form 483 issued after the inspections of those six sites. A Form 483 is the notice an FDA investigator issues at the end of an inspection to list observed concerns. The Olympus notice does not set out the specific findings.

The response clock

Olympus said it will submit a response within 15 business days of receiving the letter. It said it has already carried out substantial corrective and preventive actions, which it believes substantively address the points the letter raises. It added that it is working closely with the FDA and will keep putting patient safety first. These are the company's own assertions about its remediation; the notice gives no detail on what the actions are.

What Olympus says the letter does not do

According to Olympus, the letter does not restrict the production, sale, manufacture or distribution of its products, and it does not require a product recall. The company also said it does not restrict Olympus from applying for FDA 510(k) premarket notification clearance for new products.

On the financial side, Olympus said that, based on information available now, it does not expect the letter to affect its consolidated results. It said it will disclose material developments in line with applicable laws and regulations. The notice does not say what would count as a material development.

The account comes from Olympus alone. The notice does not reproduce the FDA letter, so the agency's own wording on the findings and on any consequences for the company is not part of the public record here.