Elevated risk U.S. Food and Drug Administration

Olympus MAJ-891 endoscope accessory recall: Risk of device contamination that may result from improper reprocessing

Recall published 1+ years ago

Risk of device contamination that may result from improper reprocessing.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: CENTER VALLEY, Pa., (January 29, 2025) – Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Published
January 29, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Olympus
Product type
Medical devices

Products covered by this recall

MAJ-891 endoscope accessory

What the company announced

CENTER VALLEY, Pa., (January 29, 2025) – Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.

The MAJ-891 is an endoscope accessory attached to the instrument channel port of certain Olympus endoscopes, including cystoscopes (CYF series), ureteroscopes (URF series), choledochoscopes (CHF series), and hysteroscopes (HYF series) to allow both irrigation and the use of endo-therapy accessories. The MAJ-891 was discontinued in 2022 from the U.S. market. The MAJ-891 is a reusable device and customers that purchased the device prior to 2022 may still be using this accessory.

Olympus assessed the issue after receiving complaints of adverse events involving patient injuries and one death. The potential harm of improper and/or incomplete reprocessing of the MAJ-891 Forceps/Irrigation Plug is exposure to a contaminated device, which could result in patient injury, specifically, infection.

Olympus notified U.S. customers about this matter by letter on December 18, 2024, recommending the following actions:

Due to the risk of infection that may result from improper MAJ-891 reprocessing, available alternative devices to the MAJ-891 for Olympus cystoscopes (CYF series) and ureteroscopes (URF series) should be used instead.

There are currently no alternative Olympus irrigation plugs for use with choledochoscopes (CHF series) and hysteroscopes (HYF series). Customers are advised to use an alternative endoscope in those situations or a non-Olympus irrigation plug, provided it has been validated for use with the Olympus endoscope by the plug manufacturer.

If no alternative for the MAJ-891 is available, it is important to closely follow the reprocessing instructions for both the endoscope(s) and the MAJ-891 Forceps/Irrigation Plug, especially detaching the MAJ-891 from the instrument channel port of the endoscope and disassembling before it is cleaned, disinfected or sterilized.

Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch program online:

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda

For information or to report a problem, please contact the Olympus Technical Assistance Center at 800-848-9024, Option 1 or email [email protected] .

Media Contacts

Stephanie Sherry, Vice President, Corporate Communications

484-896-5206, [email protected]

Susan Scerbo, Senior Manager, Public Relations

484-505-0407, [email protected]

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Model or item number

On the rating label, the box or the instruction sheet.

  • MAJ-891

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Olympus — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Olympus Corporation — Consumers: Olympus Technical Assistance Center, 800-848-9024, Option 1, [email protected] — Media: Stephanie Sherry, Vice President, Corporate Communications & Susan Scerbo, Senior Manager, Public Relations, 484-896-5206, 484-505-0407, [email protected], [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Olympus medical devices recalled?

Risk of device contamination that may result from improper reprocessing. CENTER VALLEY, Pa., (January 29, 2025) – Olympus Corporation has announced a voluntary Advisory Notice for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 related to the risk of device contamination that may result from improper reprocessing of the MAJ-891 accessory.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: model number MAJ-891. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

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