FDA blocks five more Olympus endoscopes

The Food and Drug Administration announced on Tuesday that it is preventing five more models of Olympus endoscopes made in Japan from being shipped into the United States, 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. Olympus said it is treating the warning letter and import alerts as a top priority.

Scope of the Import Alerts

The FDA’s letter to healthcare providers broadens the scope of the 2025 alert to include enteroscopes and ingestible telemetric gastrointestinal capsule imaging systems. Items refused include devices used for 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, and those currently in use may continue to be operated if users are not experiencing problems. Olympus said the alerts do not have a material impact on customers or its consolidated financial results for the fiscal year ending March 31, 2027.

The inspections revealed several serious shortcomings. At a facility in Shirakawa, Japan, Olympus failed to validate a device design and its risk‑management report did not reflect catastrophic hazards such as air embolism, arrhythmia, or patient death. The Minnesota facility reworked and distributed non‑conforming devices without adequate justification for addressing reported needle detachment, a defect that may have contributed to a patient’s death during an explant surgery. In Hachioji, Japan, the company did not identify corrective actions for a death that followed use of a bronchovideoscope, and complaints involving serious adverse events, including overpressure, cardiac arrest and a gas embolism death, were not thoroughly investigated.

Olympus says 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. In June 2025, Olympus hired Bob White, former president of Medtronic’s medical surgical business, as CEO, and a reorganization followed that included other executive changes. Olympus remains committed to addressing the FDA’s concerns and advancing its growth objectives through strengthened quality‑system governance.