Olympus endoscopes face wider FDA import block

The Food and Drug Administration said on Oct. 20 that five more models of olympus endoscopes made in Japan will be blocked from entering the United States. The move adds to 58 devices already denied entry under a June 2025 import alert. The agency said the newly blocked olympus endoscopes include certain enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems.

The agency said it still has concerns about quality system violations "despite extensive and ongoing efforts to address compliance issues." The widened block on olympus endoscopes comes two weeks after the FDA warning letter of Oct. 7, in which the agency detailed violations of quality system regulations and medical device reporting requirements found at six Olympus facilities.

The olympus endoscopes now blocked from the US

That letter followed inspections late last year at four Olympus facilities in Japan, one in Hamburg, Germany, and one in Brooklyn Park, Minnesota. The Olympus import alert covering olympus endoscopes now reaches devices used in diagnostic and therapeutic procedures in the urinary and respiratory tracts, the abdomen, pelvis and small intestine, as well as automated endoscope reprocessors. Some of the devices, including olympus endoscopes, may have been recalled, the FDA said. Devices placed on import alert but already in use may keep being used if patients and providers are not experiencing problems, the agency said. The FDA described the move as a medical device safety precaution.

What the FDA warning letter found

At a Shirakawa, Japan, facility, Olympus failed to validate a device design, and a risk management report did not account for catastrophic hazards including air embolism, arrhythmia and patient death, or ensure that risk control measures were in place, even after a death was confirmed.

At the Minnesota facility, the agency said Olympus reworked and distributed nonconforming devices without adequate justification that the work addressed reported needle detachment. In one case, the device may have contributed to a patient's death during explant surgery to recover a detached needle. At a Hachioji, Japan, facility, Olympus failed to identify corrective actions after the FDA asked for more information about a death linked to a bronchovideoscope.

Also at the Shirakawa facility, the FDA said Olympus did not adequately investigate complaints involving serious adverse events to determine whether device malfunction played a role. The complaints included reports of overpressure, cardiac arrest and possible gas embolism. One death was reported due to gas embolism. The endoscope quality violations described in the letter span design, complaint handling and corrective action.

Olympus response and quality overhaul

An Olympus spokesperson told MedTech Dive the company is treating the warning letter and the Olympus import alert as a top priority. In a separate statement, Olympus said it does not expect the import alerts to have any material impact on customers or on its consolidated financial results for the fiscal year ending March 31, 2027. The alerts do not affect imports of olympus endoscopes outside the United States.

Olympus said it has made meaningful progress in a multiyear program to strengthen its quality systems and apply consistent processes worldwide. The company has also changed its leadership, hiring people with experience in quality and regulatory improvement. "They came in with a clear mandate to deliver on the continuous and sustained improvement this situation requires," the spokesperson said. In June 2025, Olympus hired Bob White, the former president of Medtronic's medical surgical business, as chief executive, and a reorganization followed with other executive changes.

"We are fully committed to doing everything that needs to be done, and we are now moving into our next phase of work to advance the company's growth objectives supported by strengthened quality system governance," the spokesperson added.

A history of olympus endoscopes warnings

The latest action follows FDA warning letters dating back to 2022 over manufacturing practice and reporting requirements, including recalls. Those warnings came after an FDA investigation into infections tied to reprocessed duodenoscopes and urological endoscopes. The newly blocked olympus endoscopes bring the total under the import alert to 63 devices, extending a record of endoscope quality violations the agency has tracked for years, and medical device safety remains its stated concern.