When the Machine That Cleans the Scope Is Recalled

Nearly everything written about the Olympus scope cases focuses on the scope — the duodenoscope, its hard-to-clean elevator, the drug-resistant bacteria that survive reprocessing. But a scope is only as clean as the equipment that cleans it. In early 2026 the U.S. Food and Drug Administration classified a recall of that equipment: the Olympus OER-Pro and OER-Elite automated endoscope reprocessors, the machines a hospital’s sterile-processing department uses to disinfect scopes and their accessories. This article explains what an automated endoscope reprocessor is, what the recall (FDA Recall Number Z-1613-2026) actually says, and why a recall of the washer — not just the scope — is a meaningful addition to the public safety record.

What Did the FDA Recall, and What Is Affected?

The FDA classified a Class II device recall, numbered Z-1613-2026, involving the Olympus Endoscope Reprocessor OER-Pro (Model N3058140). According to the FDA recall record, Olympus initiated the correction on about February 12, 2026, notifying hospitals through an “Urgent: Medical Device Correction” letter. The stated reason is narrow but important: two reusable valve accessories — the MAJ-1443 (a suction valve) and the MAJ-1444 (an air/water valve) — are, in the FDA’s words, “no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.”

In practical terms, the recall tells hospitals to stop running those two valves through those two machines and to follow updated manufacturer instructions for use instead. The FDA record lists thousands of OER-Pro units distributed across the United States. A Class II designation is the FDA’s middle recall tier — used where a device may cause temporary or medically reversible adverse consequences, or where the probability of serious harm is remote. It is not the agency’s most serious level (Class I), but it is a formal, classified recall that becomes part of the manufacturer’s regulatory file.

What Is an Automated Endoscope Reprocessor?

An automated endoscope reprocessor (AER) is the washer-disinfector machine that performs high-level disinfection on a flexible endoscope after staff have manually cleaned it. The FDA regulates AERs as medical devices in their own right. The Olympus OER-Pro and OER-Elite are two such machines, found in the sterile-processing departments of hospitals and outpatient endoscopy centers across the country.

Reprocessing a reusable scope is a multi-step chain, and the AER is only one link in it. After a procedure, staff are supposed to pre-clean the scope at the bedside, perform a leak test, manually brush and flush every channel, and only then place the device (and certain detachable parts) into the AER for high-level disinfection or, in some workflows, sterilization. Each step depends on the one before it. If manual cleaning is incomplete, the AER cannot rescue it; and if the AER itself cannot reliably reprocess a given component, that component can come out of the machine still carrying bacteria. That is the concern at the center of this recall: the point of the AER is to kill what manual cleaning leaves behind, so a compatibility failure at the machine strikes at the last automated safeguard in the chain.

What Does “No Longer Reprocessing Compatible” Mean?

The phrase sounds bureaucratic, but its meaning is concrete. Olympus determined that the MAJ-1443 and MAJ-1444 valves should no longer be reprocessed in the OER-Pro or OER-Elite — that running those specific valves through those specific machines may not achieve the validated level of high-level disinfection the process is supposed to guarantee. When a disinfection cycle falls short, the risk is that the valve remains contaminated. Because these are reusable valves that move from patient to patient with the scope, a valve that leaves the washer still carrying organisms is a potential vehicle for patient-to-patient transmission.

It is worth being precise about what the recall does and does not claim. It does not announce a proven outbreak, and a Class II recall is not a declaration that anyone was infected. What it documents is a risk pathway — a mismatch between an accessory and the machine meant to disinfect it — serious enough that the manufacturer issued an urgent correction and the FDA classified it as a recall. Whether that pathway contributed to any particular patient’s infection is a separate, fact-specific question that turns on that patient’s own records.

How This Fits the Larger Scope-Contamination Record

The reprocessor recall does not stand alone. It sits on top of more than a decade of FDA findings that reusable duodenoscopes are difficult to clean even when hospitals do everything right. The FDA’s own post-market surveillance sampling found that roughly 1 in 20 duodenoscopes still tested positive for contamination after reprocessing, and the agency has repeatedly identified the scope’s tiny hinged “elevator” mechanism as a place where drug-resistant bacteria hide. Against that backdrop, a recall telling hospitals that the reprocessing machine itself could not reliably disinfect two reusable valves is not an isolated glitch — it is one more documented weak point in a system that has struggled with contamination for years.

The 2026 recall also has an international echo. Regulators outside the United States flagged the same compatibility problem, which we covered in our report on the Health Canada recall of Olympus endoscope parts. When two national regulators reach the same conclusion about the same accessories and machines, it reinforces that the finding reflects the device record rather than a one-off local reporting quirk.

Why a Reprocessor Recall Matters to a Patient’s Case

Scope infection claims generally proceed on two theories that can run side by side: product liability against the manufacturer of a device alleged to be defective, and negligence against a hospital for how it reprocessed the equipment. A recall of the automated reprocessor touches both. It is a manufacturer’s formal acknowledgment, memorialized in the FDA’s files, that a piece of its reprocessing ecosystem had a compatibility problem — and it adds a documented point in the reprocessing chain that a lawyer can examine when tracing where a contamination risk may have sat. Our overview of hospital reprocessing negligence explains how these responsibilities are divided.

None of that establishes any individual claim. A recall is public evidence about a device, not proof about a person. What decides a particular case is specific and personal: which scope model and which reprocessing equipment were used during the procedure, whether the valves at issue were involved, what organism was cultured from the patient, and what the hospital’s own reprocessing logs and maintenance records show. That is why these cases are built one medical chart at a time.

A Trial Lawyer’s Read

“People assume the scope is the whole story, but the cleaning system around it is just as important,” says Alex Alvarez, Managing Partner of The Alvarez Law Firm and a Board Certified Civil Trial Lawyer. “When the manufacturer has to tell hospitals that its own reprocessor can’t reliably disinfect certain reusable parts, that’s the kind of document that belongs in the file. It doesn’t win a case on its own. But it’s a fact on the public record, and in this litigation the public record is where a lot of the proof lives.”

The clinical detail is what connects a device-wide recall to one patient. “A recall like this tells me exactly what to look for in the records,” notes Herb Borroto, M.D., J.D., the firm’s Medical-Legal Expert, who holds both a medical degree and a law degree. “I want the reprocessing logs, the equipment used, whether those valves were in play, and what grew in the culture. If a reusable valve came out of a washer that couldn’t reliably disinfect it, and the same organism later showed up in the patient, that is a line worth following. The chart either supports that connection or it doesn’t — and that’s exactly the kind of question the medical record is there to answer.”

What to Do Now

If you or a loved one developed a serious infection — sepsis, a bloodstream infection, or a drug-resistant “superbug” — after an ERCP, colonoscopy, or other procedure using a reusable Olympus scope, the reprocessor recall is one more reason to have the facts reviewed while the records still exist. Reprocessing logs, equipment-maintenance files, and culture results are exactly the materials that get overwritten or discarded on routine retention schedules. Preserving them early keeps every option open. For a broader snapshot of where the litigation stands, see our June 2026 litigation status update, which first flagged this recall as part of a wider 2026 pattern.

A short, no-obligation review can tell you whether your situation fits the pattern and whether a filing deadline may be approaching. We represent patients nationwide. Free case review. No Fees Unless We Recover Money for You.

Frequently Asked Questions

What did the FDA recall in the Olympus OER-Pro reprocessor recall?

The FDA classified a Class II recall, numbered Z-1613-2026, involving the Olympus Endoscope Reprocessor OER-Pro (Model N3058140). Olympus initiated the correction on about February 12, 2026 through an Urgent Medical Device Correction letter. According to the FDA recall record, the reason is that two accessories — the MAJ-1443 and MAJ-1444 valves — are no longer reprocessing-compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. Hospitals were told to stop reprocessing those valves in those machines and follow updated instructions for use.

What is an automated endoscope reprocessor (AER)?

An automated endoscope reprocessor, or AER, is the washer-disinfector machine hospitals use to perform high-level disinfection on a flexible endoscope after staff have manually cleaned it. The FDA regulates AERs as medical devices. The Olympus OER-Pro and OER-Elite are two such machines. High-level disinfection is the step meant to kill the bacteria and other microorganisms left on a scope or its accessories, so if a machine cannot reliably reprocess a component, that component can remain contaminated.

Does the reprocessor recall mean the machine was spreading infections?

The recall does not announce a proven outbreak. A Class II recall is used when a device may cause temporary or medically reversible harm, or where the probability of serious harm is remote. The concern the FDA record describes is that reprocessing the MAJ-1443 and MAJ-1444 valves in an OER-Pro or OER-Elite may fail to achieve high-level disinfection, which could leave the valves contaminated and pose a patient-to-patient infection risk. Whether that failure contributed to any specific patient’s infection is a fact question that depends on that patient’s records.

Why does a recall of the cleaning equipment matter to a scope infection case?

Scope infection cases often turn on where in the chain a contamination risk sat — the scope’s design, how a hospital reprocessed it, or the equipment used to do that reprocessing. A recall of the automated reprocessor itself adds a documented point in that chain and is part of the public regulatory record a lawyer can review. It does not, by itself, prove any individual claim. What matters for a given patient is which scope and which reprocessing equipment were used, what organism was cultured, and what the records show.

Sources

• U.S. Food & Drug Administration — Class 2 Device Recall, “Olympus Endoscope Reprocessor OER-Pro” (Recall Number Z-1613-2026; Model N3058140; correction initiated by firm February 12, 2026; reason: MAJ-1443 and MAJ-1444 no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors). accessdata.fda.gov
• U.S. Food & Drug Administration — “Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation” (what an AER is and how it fits the reprocessing of reusable endoscopes). fda.gov
• U.S. Food & Drug Administration — “Infections Associated with Reprocessed Duodenoscopes” (post-market surveillance sampling and contamination-after-reprocessing findings for reusable duodenoscopes). fda.gov
• U.S. Food & Drug Administration — Medical device recall classifications and definitions (Class I, II, and III recall tiers). fda.gov

This article is for general informational purposes only and is not legal or medical advice. It summarizes the public status of a classified medical-device recall and general reprocessing concepts as of the publication date; regulatory status can change, and this article does not describe the outcome of any client’s case. A recall is evidence about a device, not proof about any individual’s injury. Nothing here creates an attorney-client relationship, and no result is promised or implied. Past results do not guarantee future outcomes. Deadlines and legal standards vary by state and by the facts of each case. If you believe you may have a claim, consult a licensed attorney promptly.