Endoscopic Procedures Lawsuit Update: Injuries, Recall Status, and Legal Options

Olympus endoscopes and accessories have been recalled in FDA records for infection after reprocessing, detached parts and tissue injury. The devices include a duodenoscope, a distal cover, reprocessors, a plug, a needle and a ligating device. No MDL has been formed for endoscopic procedures or the Olympus recalls. FDA lists four of the Olympus recall records as Open, Classified. Injury figures come from Olympus and FDA reports, not from court filings. The newest FDA record, from July 7, 2026, covers the MAJ-2315 distal cover, which Olympus has redesigned. The recalled devices are used in procedures such as ERCP, cystoscopy, lung needle biopsy and polyp removal.

Latest Endoscopic Procedures Lawsuit Updates

July 7, 2026: FDA Posts Olympus Distal Cover Recall

FDA posted a Class 2 recall record for the Olympus Single Use Distal Cover. The catalog number is MAJ-2315 and the recall number is Z-2676-2026 [1]. Olympus began the action on June 5, 2026, to replace the previous design with a newly designed cover. The record lists 988,700 units, US nationwide, with lot numbers H2530 or later.

March 20, 2026: FDA Posts Olympus Reprocessor Recall

FDA’s Class 2 record covers the Olympus Endoscope Reprocessor OER-Elite, model number N5789340. The recall number is Z-1612-2026 [2]. FDA determined the cause to be reprocessing controls. Olympus told customers on or about February 12, 2026. The MAJ-1443 and MAJ-1444 valves are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors. The record lists 2,929 units.

January 16, 2026: Olympus Expands ViziShot Needle Removal

The Olympus announcement of January 16, 2026 expanded its removal of ViziShot 2 FLEX (19G) EBUS-TBNA needles to all lots. FDA posted it, and it supersedes the August 2025 notice [3]. The company cited complaints of device parts ejecting or detaching during procedures. The complaints included adverse event reports of patient injury and one death. Users are told to cease use immediately and quarantine all devices.

November 21, 2025: FDA Posts Olympus Duodenoscope Recall

The Olympus EVIS EXERA III duodenovideoscope TJF-Q190V has a Class 2 recall record, number Z-0579-2026 [4]. The record covers 7,023 units, all serial numbers. Olympus sent correction letters on October 14, 2025. They followed continued reports of positive cultures and infections. Olympus reminded users to follow the operation and reprocessing instructions. It also gave them updated materials.

November 3, 2025: Olympus Updates PolyLoop Instructions

Olympus sent customers a letter on November 3, 2025, as part of the PolyLoop correction. It updates the instructions for use of the Single Use Ligating Device PolyLoop (HX-400U-30) [5]. As of October 1, 2025, Olympus had reported 113 serious injuries and no deaths. The action updates instructions and does not remove the devices from where they are used or sold.

August 6, 2025: Olympus Sends ViziShot Removal Letter

The ViziShot 2 FLEX (19G) removal letter of August 6, 2025 was an Urgent Medical Device Removal letter from Olympus. It covered certain lots of the needle [6]. FDA reports 40 injuries and one death related to the issue. The needle is designed for use with ultrasound endoscopes. It serves ultrasound guided fine needle aspiration and fine needle biopsy.

December 27, 2024: Health Canada Posts MAJ-891 Recall

Health Canada published a Type I health product recall notice for the Olympus MAJ-891 forceps/irrigation plug. The notice lists identification number RA-76768 and a recall start date of December 20, 2024 [7]. It describes infections reported between August 1, 2021 and May 1, 2024. Olympus’s investigation indicates improper reprocessing in most of these infection cases.

December 23, 2024: FDA Posts MAJ-891 Plug Alert

The FDA early alert of December 23, 2024 covers the Olympus MAJ-891 forceps/irrigation plug, all lots. Olympus had sent customers an Urgent: Medical Device Advisory Notice on December 18, 2024 [8]. FDA later identified the recall as the most serious type. Olympus reported 120 injuries and 1 report of death due to infection. These followed procedures in which the plug was used with a cystoscope.

March 13, 2024: FDA Terminates 2021 Duodenoscope Recall

FDA terminated the 2021 Olympus TJF-Q190V recall, number Z-1292-2021, on March 13, 2024. Olympus began that action on January 28, 2021 [9]. It followed complaints of mucosal injury associated with the forceps elevator region of the duodenoscope, including the distal cover (MAJ-2315). The record covers 1,564 devices. It lists the cause as under investigation by the firm.

February 9, 2024: FDA Posts Earlier Distal Cover Recall

The earlier Class 2 recall record for Olympus Single Use Distal Cover MAJ-2315 carries recall number Z-1071-2024 [10]. Olympus had sent a corrective action letter on December 8, 2023. The cover may unexpectedly detach from the duodenoscope during use. FDA lists burns from an uncovered distal end among the risks. The record lists 24,300 units, in a box of 20 pieces.

What Are Endoscopic Procedures?

According to MedlinePlus, endoscopy is a procedure that lets your doctor look inside your body. It uses an instrument called an endoscope, or scope. Scopes have a tiny camera attached to a long, thin tube [11]. The doctor moves it through a body opening to see inside an organ. Sometimes scopes are used for surgery, such as removing polyps from the colon.

Who May Be Affected?

Patients who had a procedure with a recalled Olympus device may be affected. A legal review looks at one person’s own procedure, device and records. FDA records name these cases:

• An ERCP done with the TJF-Q190V duodenoscope or its single use MAJ-2315 distal cover.
• A procedure with the MAJ-891 plug on a cystoscope (CYF series), ureteroscope (URF series), choledochoscope (CHF series) or hysteroscope (HYF series).
• A lung needle biopsy with a ViziShot 2 FLEX (19G) needle distributed between August 4, 2022 and April 25, 2025.
• Removal of a pedunculated polyp with a PolyLoop HX-400U-30 device made between September 22, 2022 and September 7, 2025.
• Any scope reprocessed in an OER-Pro or OER-Elite reprocessor with MAJ-1443 or MAJ-1444 valves.

Reported Injuries or Damages

These injuries come from FDA recall records and Olympus reports. A report does not prove that a device caused an injury in a given patient. FDA names these risks:

• MAJ-891 plug: infection, urinary tract infection or sepsis, and in some cases death. These may need hospital care and antibiotics.
• PolyLoop device: if the loop will not release, severe tissue or mucosal injury, perforation, and bleeding that may need transfusion. More surgery and hospital care may follow.
• ViziShot needle: loose parts in the airways can cause mucosal injury and bleeding, or need extra procedures to remove them.
• MAJ-2315 distal cover: tissue damage, bleeding, perforation or obstruction that needs urgent removal. In the mouth, a detached cover may cause aspiration or airway obstruction.

The FDA duodenoscope infection page gives one key finding. Tissue or fluid left in a scope that was not thoroughly cleaned can, in rare cases, pass infection to the next patient [12]. The same page says these infections occurred even when users followed the maker’s cleaning instructions. Duodenoscopes are used in more than 500,000 ERCP procedures each year in the United States.

Recall and Regulatory Background

FDA calls the MAJ-891, PolyLoop and August 2025 ViziShot actions the most serious type. A recall does not prove liability. Remedies include a new distal cover design, updated instructions and training. Olympus lists its Technical Assistance Center at 1-800-848-9024, option 1. Adverse reactions may be reported to the FDA MedWatch program [13].

Evidence to Preserve

Keep the records and items that show which device was used and what happened next:

• The procedure report, hospital records, scans and discharge papers from the facility.
• Lab and culture results, records of antibiotics given, and any blood transfusion records.
• The model and serial number of the scope or device used, plus the facility’s logs for cleaning each scope.
• Any recall or correction letter the facility got, and your messages with the facility or Olympus.
• Photos of your injuries, any device part that was recovered, and your medical bills.
• The name of the facility and the date of each procedure, so the device can be traced.

Filing Deadlines

Filing deadlines exist for injury claims, and they are set by the law of the state where the claim is brought. The period depends on where you live and when the procedure, the infection or injury and the diagnosis happened. Some states start the clock at diagnosis. Missing a deadline can end a claim even when the facts are strong, so speak with a lawyer promptly after a serious complication.

Frequently Asked Questions

Can You Get an Infection from a Contaminated Endoscope?

You can get an infection from a contaminated endoscope, but FDA says it happens in rare cases. In the fall of 2013, the CDC alerted FDA to a potential association between multi-drug resistant bacteria and duodenoscopes.

Can You Get Sepsis from a Colonoscopy?

The FDA MAJ-891 alert does not name sepsis from a colonoscopy. It names sepsis as a risk of the plug used with cystoscopes. Health Canada’s notice says Olympus received no infection complaints with ureteroscopes, choledochoscopes, hysteroscopes or ventriculoscopes, though the risk applies to them.

What Does the Research Say About Endoscope Infections?

FDA’s research on endoscope infections finds that newer duodenoscope models can reduce infection risk compared with older fixed endcap models, as of June 30, 2022. FDA issued Warning Letters to the three duodenoscope makers, Olympus among them, on March 9, 2018.

Is the MAJ-891 Plug Still Sold in the United States?

The MAJ-891 plug is no longer sold in the United States, FDA says, because it was discontinued in 2022. Olympus recommends alternatives, including the Luer-Split model MAJ-2092 and the Seal-Port model BPS-Y for CYF and URF scopes.

What Caused the PolyLoop Release Problem?

Olympus’s preliminary investigation attributed the PolyLoop release problem to two things. One is moving the yellow tube joint away from the handle during use. The other is forcing the slider when resistance is met. FDA says users may continue to use the device with the updated instructions.

Are Other EBUS-TBNA Needles Part of the ViziShot Recall?

Other EBUS-TBNA needles are not part of the ViziShot recall. The ViziShot 2 FLEX heat-shrink material can degrade during use. A hypotube component could eject, or plastic parts could detach and enter the airways.

What Should I Do If Part of a Scope Broke During an Endoscopic Procedure?

If part of a scope broke during an endoscopic procedure, seek medical care. Ask the facility which device was used, including its model and serial number, and for any recall letter it received.

References

1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=220844
2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=218481
3. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-expands-voluntary-recall-vizishot-2-flex-19g-ebus-tbna-needles
4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=216332
5. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/correction-alert-olympus-updates-use-instructions-ligating-device
6. https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/endoscopic-aspiration-needle-recall-olympus-removes-certain-vizishot-2-flex-19g-needles-due
7. https://recalls-rappels.canada.ca/en/alert-recall/forcepsirrigation-plug
8. https://www.fda.gov/medical-devices/medical-device-recalls/update-alert-endoscope-accessories-forcepsirrigation-plug-issue-olympus
9. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=185744
10. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=205324
11. https://medlineplus.gov/endoscopy.html
12. https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/infections-associated-reprocessed-duodenoscopes
13. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program