The Food and Drug Administration said Tuesday it is preventing five more models of Olympus endoscopes manufactured in Japan from being shipped into the U.S., adding to a list of 58 devices already denied entry under a June 2025 import alert.
The update follows an Oct. 7 warning letter in which the FDA detailed violations of quality system regulations and medical device reporting requirements after inspecting six Olympus facilities.
An Olympus spokesperson said in an email to MedTech Dive that the company is treating the warning letter and import alerts as a top priority.
The FDA letter to healthcare providers on imports broadens the scope of the 2025 alert to include certain enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems. The agency said it continues to have concerns related to outstanding quality system regulation violations “despite extensive and ongoing efforts to address compliance issues.”
In total, items refused entry into the U.S. include devices to perform diagnostic and therapeutic procedures in the urinary and respiratory tracts, abdomen, pelvis and small intestine, as well as automated endoscope reprocessors. Some of the devices may have been recalled, the FDA said.
Devices subject to the alert but currently in use may continue to be operated if users are not experiencing problems with them, the agency said.
In a separate statement, Olympus said it does not expect the import alerts to have any material impact on customers or incremental effects on its consolidated financial results for the fiscal year ending March 31, 2027. The alerts also do not affect import of the products outside the U.S.
FDA warning letter
The FDA’s latest actions follow a series of warning letters dating back to 2022 issued to Olympus over manufacturing practice and reporting requirements, including recalls. Those warnings came after an FDA investigation into infections tied to reprocessed duodenoscopes and urological endoscopes.
Before issuing the new warning letter, which the FDA posted Tuesday, the agency conducted inspections late last year at four Olympus facilities in Japan; one in Hamburg, Delaware; and one in Brooklyn Park, Minnesota. Among the findings:
- At a facility in Shirakawa, Japan, Olympus failed to validate a device design, and a risk management report did not reflect catastrophic hazards, including air embolism, arrhythmia and patient death or ensure implementation of risk control measures, even after a death was confirmed.
- At the Minnesota facility, Olympus reworked and distributed nonconforming devices without adequate justification that the work addressed issues of reported needle detachment. There was one instance where the device may have contributed to a patient’s death during explant surgery to recover a detached needle.
- In Hachioji, Japan, Olympus failed to identify corrective actions in response to the FDA’s request for additional information related to a death that followed use of a bronchovideoscope.
- Also at the Shirakawa facility in Japan, Olympus failed to adequately investigate complaints involving serious adverse events to determine whether device malfunction contributed. Complaints included reports of overpressure and outcomes such as cardiac arrest and possible gas embolism. One death was reported due to gas embolism.
Olympus said it has made meaningful progress in a multiyear quality system transformation program designed to strengthen operations and apply consistent processes globally. The company has also strengthened its leadership team, bringing in leaders with direct experience driving 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 CEO. A reorganization followed that included 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,” said the spokesperson.
