About a year ago, Olympus's then-CEO told investors the company expected to finish all of its outstanding quality commitments to the FDA by the end of its fiscal year — March 31, 2026. That date has now passed. The headline for May 2026 is that Olympus says it is 96% of the way to the finish line, but the FDA import alert on 58 of its devices is still in place, and new lawsuits keep being filed in the United States and abroad.
What Olympus Says It Has Finished
In its most recent investor disclosures, Olympus reports that it has completed roughly 96% of the corrective actions tied to the FDA's quality system findings. That number comes from the company's own filings — it is not an FDA certification.
The remaining 4% matters. The FDA has not lifted the June 24, 2025 import alert that blocks Olympus from shipping 58 specific device models from its Aizu, Japan facility into the United States. Until the FDA independently verifies that the underlying violations are fixed, those devices remain barred from import. Hospitals that already have the affected scopes can keep using them under the FDA's existing labeling guidance, but new units cannot enter the country.
For patients, this means two things: the regulatory cloud over Olympus is not gone, and the FDA's own documentation of quality problems — which is critical evidence in product liability cases — continues to grow.
A New Class Action in Canada (April 2026)
On April 13, 2026, the Quebec affiliate of Canadian law firm Siskinds LLP filed an application in the Superior Court of Quebec seeking authorization to bring a class proceeding on behalf of Canadians harmed by Olympus endoscope procedures. The filing alleges the devices contain safety defects and put patients at high risk of infection.
A Canadian class proceeding does not directly affect U.S. patients' rights or U.S. cases. But the filing is meaningful for two reasons. First, it confirms that the same safety story now being raised in U.S. lawsuits is being pursued in another country with its own court system and its own document discovery. Second, additional jurisdictions putting Olympus through litigation increases the volume of evidence, depositions, and internal documents that may eventually become available across borders.
That same month, Health Canada issued a recall affecting certain Olympus endoscope components after determining they were no longer compatible with some automated cleaning systems — a fresh data point on the cleaning and reprocessing problems at the heart of these cases.
U.S. Cases: Still Individual, Still Filing
Nothing structural has changed in the U.S. since our April 2026 litigation status update. There is still no MDL (multidistrict litigation), and the Judicial Panel on Multidistrict Litigation has not consolidated the cases. Plaintiffs continue to file individual product liability actions in state and federal courts across the country.
The FDA's adverse event database (MAUDE) continues to record new infection reports tied to Olympus duodenoscopes. From 2024 through early 2026, the FDA has documented two deaths and five serious injuries connected to infection or positive cultures involving the TJF model duodenoscope alone — and that is just one device family within the broader scope portfolio.
For prospective plaintiffs, the practical question is the same one we've been emphasizing all year: your filing window is set by your state's statute of limitations, and it does not pause while you wait to see whether an MDL forms. If you developed a serious infection after an Olympus scope procedure, the calendar is the most important variable.
What to Watch the Rest of 2026
A few specific developments that could change the picture in the second half of the year:
- FDA verification. The agency has not announced that it has verified Olympus's claimed 96% completion. If the FDA confirms the work and lifts the import alert, that would be a meaningful regulatory shift. If the FDA instead identifies further violations, the import alert could expand or trigger additional enforcement.
- Possible MDL motion. If U.S. federal filings continue to rise, plaintiffs' counsel could move the JPML to consolidate. Once that motion is filed, a decision typically follows within months.
- More FDA-mandated notices. Olympus has continued to issue urgent field correction notices to hospitals on individual scope models. Each notice updates cleaning instructions or warns of newly identified risks — and each one becomes part of the regulatory record in private lawsuits.
- International discovery. Documents produced in the Canadian proceeding, as well as in any European actions, can become persuasive evidence in U.S. cases through normal discovery channels.
- Continued bellwether positioning. Even without an MDL, large plaintiff firms are positioning lead cases that could establish liability templates other lawsuits would follow.
If You Were Affected
The pattern we keep seeing is the same: a patient had a colonoscopy, ERCP, or other endoscopic procedure, was sent home, and within days or weeks developed a serious infection that nobody connected back to the scope at the time. Often the connection only becomes clear months or years later — usually after a hospital outbreak is reported, or after a news story prompts the patient to ask questions.
We represent patients nationwide, regardless of where the procedure happened. A free case review takes about 15 minutes by phone, and we evaluate the medical timeline, the device involved, and your state's filing deadlines before you decide whether to move forward.
- See if your situation fits the case profile with our 3-part qualification test.
- Learn how to identify which scope was used in your procedure: Did Your Hospital Use Olympus Scopes?
- Review the superbug infection symptoms guide for warning signs to watch for.
- Read the underlying regulatory backdrop: What the June 2025 FDA Import Alert Means for You.
Free case review. No Fees Unless We Recover Money for You.
Sources
- U.S. Food & Drug Administration — "Import Alerts for Certain Olympus Medical Devices Manufactured in Japan: Letter to Health Care Providers." fda.gov
- Olympus Corporation — "Acknowledges FDA Import Alerts for Certain Devices Manufactured at Aizu Facility, Japan" (2025 news release). olympus-global.com
- Olympus Corporation — "Consolidated Financial Results for Fiscal Year 2025 and 1st Quarter Fiscal Year 2026" (investor materials, including disclosures on quality-commitment progress). olympus-global.com/ir
- MedTech Dive — "FDA stops Olympus devices from entering the US" and "Olympus pledges prompt response following FDA import block." medtechdive.com
- Healthcare Dive — "FDA stops Olympus devices from entering the US." healthcaredive.com
- Siskinds LLP — "Class action pursued over infection risks linked to endoscope devices" (April 2026, Quebec). siskinds.com
- U.S. FDA MAUDE Adverse Event Database — reports involving Olympus duodenoscope models. accessdata.fda.gov
- Judicial Panel on Multidistrict Litigation — pending MDL list. jpml.uscourts.gov
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.