On June 24, 2025, the U.S. Food and Drug Administration issued an import alert blocking 58 different Olympus endoscope models from entering the country. If you or a loved one was hurt by a contaminated scope, this news matters — even if your procedure happened years before the alert was issued.
What an Import Alert Actually Does
An FDA import alert is one of the most powerful tools U.S. regulators have against a foreign medical device maker. When a product is placed under an import alert, U.S. Customs and Border Protection is authorized to detain every listed product at the border. The manufacturer has to prove to the FDA that the product is safe — batch by batch, shipment by shipment — before anything gets released into the U.S. market.
In other words: the FDA does not trust the manufacturer to police itself. Import alerts are reserved for manufacturers who have a documented history of serious problems, and they are very hard to get out from under once issued.
Why This Import Alert Is Different
This was not the FDA's first warning about Olympus scopes. The 2025 import alert came more than a decade after the first known outbreak linked to Olympus duodenoscopes, seven years after the 2018 Department of Justice deferred prosecution agreement that required Olympus Medical Systems Corporation to pay $85 million, and nine years after the FDA first formally acknowledged that standard cleaning of these scopes was not enough to keep patients safe.
In that time, Olympus redesigned its flagship duodenoscope, issued recalls, and repeatedly told the FDA it had the problem under control. The 2025 import alert was the FDA's formal acknowledgment that, after all those promises, the risk had not been adequately addressed.
What the 58 Models Include
The import alert covers 58 specific Olympus endoscope models — a list that extends well beyond just the ERCP duodenoscopes that sat at the center of the earliest outbreaks. The fact that the FDA cast such a wide net suggests a pattern: concerns about Olympus's manufacturing, reprocessing guidance, and adverse event reporting were broad, not limited to one product line.
If you had any endoscopic procedure performed with an Olympus scope, that may now be relevant to your case — not just patients who had ERCP. Check the list of affected procedures to see which endoscopies use reusable scopes covered by the contamination concerns.
Why It Matters for Patients Hurt Before 2025
This is the part most patients don't realize: a 2025 import alert can be used as evidence in a case about an infection that happened years earlier. Here's why.
When the federal government formally finds — on the record — that a device is dangerous enough to block from the market, that finding becomes part of the public record. It can be cited. It can be used to support expert testimony. And it makes it harder for Olympus to argue in civil cases that its scopes were "generally safe" at the time earlier patients were hurt.
The 2018 DOJ guilty plea is part of the federal record establishing that Olympus knew about outbreaks it had not reported to U.S. regulators. The 2025 import alert adds to that record, confirming that problems persisted for years after Olympus said they had been fixed. For patients harmed by these scopes — whose realistic chance to learn the truth came only with the 2025 and 2026 wave of consumer news coverage — the federal paper trail supporting their cases keeps getting stronger.
What This Means for Your Case
If you had an endoscopic procedure with an Olympus scope and developed a serious infection afterward, the import alert is one more piece of evidence that supports a case. You do not need to have had your procedure after June 2025 — in fact, the discovery rule is built precisely for patients whose procedures predate the wave of consumer reporting in 2025 and 2026. You do not need the specific scope model in your records, either (we request those as part of the free review).
What you do need is a straightforward story: a procedure, an infection that followed, and enough documentation to trace the pathogen and the timeline. Our team — including Herb Borroto, M.D., J.D. — handles the rest. If you're not sure whether your situation fits, the 3-part qualification test takes about 2 minutes to read through.
The Bigger Picture
The June 2025 import alert is the moment this story finally broke into mainstream consumer news. The underlying device problem — which had been documented in federal records since at least 2012 but kept largely out of view of ordinary patients — is the same problem reusable scopes still carry today. As long as reusable scopes remain in clinical use, patients will continue to be exposed to it.
If you think a contaminated Olympus scope may have caused you harm — whenever the procedure happened — it is worth the 15 minutes of a free case review. The discovery rule keeps many older cases alive, and the only way to know is to ask. No Fees Unless We Recover Money for You.
Think You May Have a Case?
The 3-part qualification test takes 2 minutes. If it fits your situation, a free case review is the next step. No Fees Unless We Recover Money for You.