Olympus MAJ-891 Forceps and Irrigation Plug Recall — 30,140 Units, 120+ Injuries, 1 Death

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Olympus Scope — Infection Claims

Hospitalized With an Infection After a Scope Procedure?

If you were told it was “just a complication,” Olympus’s federal guilty plea — and $85 million in penalties — tell a different story. In two minutes, you can know whether your case qualifies.

ACTIVE LITIGATION. 250+ patients · most recent filing: June 2026 · deadlines vary by state — some as short as one year.

Were you hospitalized with an infection within 30 days of an endoscopy or scope procedure?

Yes — See If My Case Qualifiesfree · takes 2 minutes
I think so / not sure

Free · confidential · no fee unless there is a recovery · answering doesn’t commit you to anything. Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

Prefer to talk it through? (888) 348-2735 — free and confidential.

Stefanie A. Murphy & Matthew T. Marin

Partners

You’ll get a straight answer even if it’s “you don’t qualify.” Everything you share is confidential — even if you never hire us. No fee unless there is a recovery; costs are advanced and reimbursed only out of a recovery. If you do qualify, our Olympus scope litigation team requests the medical and hospital records — you don’t chase them.

Qualification depends on what the medical records show — the scope involved, the infection, and the timing. We’ll review them and give you a straight answer either way.

Court costs and litigation expenses are advanced by counsel and repaid from the recovery. You are not responsible for court costs or litigation expenses if there is no recovery, unless a court directs otherwise. The attorney’s fee is a percentage of the gross recovery, calculated before expenses are deducted.

What Is the Olympus MAJ-891 Recall?

The Olympus MAJ-891 Forceps and Irrigation Plug is an endoscope accessory used with Olympus duodenoscopes during ERCP (Endoscopic Retrograde Cholangiopancreatography) procedures. ERCP is the most commonly performed procedure linked to confirmed infection outbreaks in the Olympus scope litigation, with approximately 500,000 to 650,000 ERCPs performed annually in the United States using Olympus devices. (Source: FDA Safety Communication, February 2015.) On December 18, 2024, Olympus Corporation of the Americas initiated a Class I FDA Recall of the MAJ-891.

The recall was posted to the FDA database on January 16, 2025. Recall number: Z-0905-2025. Recalling firm: Olympus Corporation of the Americas, 3500 Corporate Pkwy, Center Valley PA 18034. Class I is the FDA’s most serious recall classification — reserved for situations where use of the recalled product carries a reasonable probability of causing serious adverse health consequences or death. 30,140 units of the MAJ-891 were distributed in the United States.

The manufacturer’s stated reason for the recall was the potential for inadvertent retention of biomaterial when reprocessing is not performed as instructed, preventing complete removal and disassembly of the device. The FDA determined the root cause to be labeling design — meaning the device’s own instructions were insufficient to prevent this failure mode. (Source: FDA Recall Z-0905-2025.) Over 120 reported injuries and one confirmed death have been associated with the MAJ-891 recall.

The recall action language states the device can result in infection, urinary tract infection, or sepsis and, in some cases, could result in death. The 120+ injury and death figures derive from MAUDE (Manufacturer and User Facility Device Experience) adverse event reports.

What Injuries and Deaths Are Linked to the MAJ-891?

The MAJ-891 recall is associated with over 120 reported injuries and one confirmed death in the FDA adverse event database. The device’s failure to fully release retained biological material during reprocessing creates a direct pathway for bacteria to survive the cleaning cycle and re-contaminate the next patient who undergoes a procedure with the same device or scope system. The injuries associated with the MAJ-891 include infection, urinary tract infection, and sepsis — consistent with the broader pattern of infections linked to contaminated Olympus endoscope accessories.

Sepsis from a contaminated medical device is a life-threatening condition that requires emergency hospitalization, IV antibiotic treatment, and in severe cases, admission to an intensive care unit. The MAJ-891 recall is part of an unbroken pattern of Olympus enforcement failures. The device joins the TJF-Q180V recall (January 2016), the TJF-Q190V Urgent Field Safety Notice (October 2025), the BF-1TH190 bronchoscope recall (June 2023), and the ViziShot 2 FLEX recall (September 2025) as Olympus products subject to the FDA’s most serious enforcement actions.

(Sources: FDA Recall Z-0905-2025; Olympus Urgent Field Safety Notice, October 14—17, 2025.)

How Does the MAJ-891 Cause Infection?

The MAJ-891 causes infection through a mechanism consistent with the broader duodenoscope contamination problem: retained biological material that cannot be fully removed during reprocessing creates a reservoir for bacteria to survive between procedures. The FDA determined that the root cause of the MAJ-891 recall was labeling design — meaning the device’s own instructions for cleaning and reprocessing were insufficient to prevent biomaterial retention.

When a patient undergoes a procedure and the MAJ-891 accessory is used, organic tissue fragments, blood, and bacteria can become trapped in the device’s internal structures. If those materials are not fully removed during the reprocessing cycle — and the FDA’s investigation confirmed they often were not — the next patient to undergo a procedure is exposed to the prior patient’s biological material. Independent research has confirmed that this contamination problem is not limited to the MAJ-891.

A 2022 meta-analysis of 9,084 post-reprocessing cultures found 5% contamination even after enhanced cleaning protocols beyond standard high-level disinfection, including 0.8% high-risk organisms. (Source: Bomman et al., Clinical Endoscopy, January 2022, PMC8831410.) An 8-year retrospective study at a Dutch tertiary-care hospital found measurable bacterial contamination in 94.7% of patient-ready duodenoscopes by 2022, despite all manufacturer-recommended protocol upgrades including new equipment and staff training.

All Olympus-recommended interventions failed to produce meaningful improvement over the entire 8-year study period. (Source: van der Ploeg et al., Gut, March 2024, PMID 38182137.) The MAJ-891’s design defect is part of the same systemic problem: an accessory component that creates a reservoir for bacteria that standard reprocessing cannot reliably eliminate, used in conjunction with scopes that face the same contamination challenge at the elevator mechanism level.

The combined contamination risk of the scope plus recalled accessory is the design defect at issue. For a full account of Olympus’s knowledge of these problems, see the Olympus criminal history page.

What Is the MAJ-891 Used For?

The MAJ-891 Forceps and Irrigation Plug is an accessory component used with Olympus duodenoscopes during ERCP procedures. ERCP — Endoscopic Retrograde Cholangiopancreatography — is a procedure in which a flexible endoscope is inserted through the mouth and guided into the small intestine to examine and treat conditions affecting the bile duct, pancreatic duct, and gallbladder. ERCP is used to diagnose and treat conditions including gallstones, bile duct blockages, pancreatitis, and biliary strictures.

ERCP is the procedure most consistently linked to confirmed infection outbreaks in the Olympus scope litigation. Approximately 500,000 to 650,000 ERCPs are performed annually in the United States, the majority using Olympus duodenoscopes. The MAJ-891 accessory is used in a subset of these procedures as a port plug component that interfaces with the scope’s irrigation and instrument channels — the same internal channels where contamination accumulates.

Patients who underwent ERCP procedures at any U.S. hospital between 2015 and the present using Olympus equipment — including the MAJ-891 accessory — should review whether the MAJ-891 was used in their procedure and whether they developed an infection requiring hospitalization. Medical records from the procedure date should include the specific device accessories used.

What Qualifying Injuries May Support a Legal Claim?

A patient may have a qualifying MAJ-891 recall lawsuit if all of the following apply: Procedure date: The procedure was performed on or after January 1, 2015, using an Olympus bronchoscope, upper GI endoscope (including duodenoscopes, gastroscopes, or enteroscopes), or colonoscope — including procedures where the MAJ-891 accessory was used. Confirmed infection: A confirmed infection diagnosis is required.

Inpatient hospitalization: Inpatient hospitalization for the infection is required. Outpatient treatment with oral antibiotics alone does not qualify. IV antibiotic treatment: IV antibiotic treatment during hospitalization is required. Infection timing: The infection and resulting hospitalization occurred within 30 days of the scope procedure. Most patients in this litigation developed symptoms within approximately five days.

No disqualifying comorbidities: The patient must not have been undergoing dialysis or chemotherapy at the time of hospitalization.

Device disintegration — separate claim: If the MAJ-891 or any scope component broke apart during the procedure and required emergency surgery to remove fragments, this may represent a separate product liability claim with no 30-day infection window requirement. Even if you believe your filing deadline may have passed, contact us before assuming you have no options. Call (888) 348-2735 for a free case evaluation.

What Should I Do If I Was Exposed to the MAJ-891?

1. Contact an attorney immediately. Do not wait. Filing deadlines vary by state — Tennessee patients have only 1 year. Every day without legal consultation is a day closer to your deadline.
2. Request your procedure records. Ask the facility where the procedure was performed for the full procedure report, the device accessory documentation, microbiology culture results, hospitalization records, and discharge summary. The procedure report should identify the specific accessories used.
3. Save any letters from your hospital. If you received a letter from the facility about the MAJ-891 recall or a potential contamination event, keep it. It is evidence of exposure.
4. Do not discuss your case with the hospital’s risk management team before speaking with an attorney.
5. Do not assume you do not qualify. Let an attorney evaluate your specific situation — many patients self-disqualify based on incorrect assumptions. Call Marin & Murphy at (888) 348-2735.

Frequently Asked Questions

Attorney Advertising. Marin & Murphy Law Firm. Prior results do not guarantee a similar outcome.

Attorney Advertising. This page is general information, not legal advice, and does not create an attorney-client relationship — that relationship is formed only by a signed written agreement. The attorneys of Marin & Murphy Law Firm are licensed in Rhode Island, South Carolina, Connecticut, and Massachusetts. We evaluate potential claims nationwide; for matters arising in states where our attorneys are not admitted, we associate with or refer to locally licensed co-counsel and do not ourselves practice law in those jurisdictions.

Submitting the contact form or contacting the firm does not create an attorney-client relationship. Representation is offered on a contingent-fee basis: no fee unless there is a recovery, though a client may be responsible for case costs and expenses. The statute of limitations may sharply limit the time to file a claim. Prior results do not guarantee a similar outcome, and no outcome is guaranteed. Responsible attorney: Matthew T.

Marin, Marin & Murphy Law Firm (Rhode Island).