The FDA is notifying healthcare providers about import alerts for certain medical devices manufactured in Japan by Olympus and its subsidiaries.
According to a notice, the FDA has “concerns related to outstanding quality system regulation violations by Olympus.” The agency cites “extensive and ongoing efforts to address compliance issues” with the company as well. As a result, it issued import alerts to prevent future shipments of certain devices manufactured in Japan from entering the U.S.
Devices included in the warning are ureterorenoscopes, bronchoscopes, laparoscopes and automated endoscope reprocessors. (The FDA lists 58 devices subject to its import warning. See the full list here.)
This isn’t the first instance of FDA scrutiny surrounding Olympus devices made in Japan. The agency sent Olympus a warning letter in 2023 related to adultered endoscopes following an inspection of the company’s Tokyo facility. The company received two separate letters at the end of 2022 as well.
In its warning, the FDA recommends that providers remain aware of alerts for devices manufactured at Aizu, an Olympus site in Japan. The agency determined that certain facilities in Japan weren’t in compliance with current good manufacturing practice (CGMP) requirements and various reporting requirements. That includes for recalls identified as the most serious kind by the FDA. However, providers may continue using devices subject to the import alert if not experiencing problems with them.
“The FDA is continuing to engage with Olympus to accelerate corrective actions related to ongoing violations and minimize risk to patients, and may take further action as appropriate,” the FDA notice said. “FDA takes seriously its role in assuring patients that medical devices are safe and effective.
“The FDA will continue to keep health care providers and the public informed if new or additional information becomes available.”
The news sent Olympus stock (TYO: 7733) down more than 10% today on the Tokyo exchange.
