Skip to content
Lower risk Medical device recall · FDA · Published December 18, 2024

Olympus MAJ-891 Forceps: Risk of retained biomaterial during reprocessing

Olympus recalls MAJ-891 Forceps/Irrigation Plug due to potential biomaterial retention if not properly disassembled during reprocessing. Affected units sold with model number MAJ-891.

🇺🇸 FDA recall #Z-0905-2025Medical deviceOlympus ›
Take action

Contact the company

Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

What happened, in plain English

Olymp: Olympus recalls its MAJ-891 Forceps/Irrigation Plug for possible retained biomaterial if not completely disassembled during reprocessing. This could lead to infection or other complications if the device is not properly cleaned. Read more at govinfonow.com/recall/53268-olympus-maj-891-forceps-risk-of-retained-biomaterial-during-reprocessing.

Source Summary by GovInfoNow · govinfonow.com/recall/53268-olympus-maj-891-forceps-risk-of-retained-biomaterial-during-reprocessing · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0905-2025

Cite this page

“Olympus MAJ-891 Forceps: Risk of retained biomaterial during reprocessing.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53268-olympus-maj-891-forceps-risk-of-retained-biomaterial-during-reprocessing. Based on FDA recall #Z-0905-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0905-2025%22&limit=1).

Why it’s dangerous

The forceps may retain biomaterial if not fully disassembled during reprocessing. This could lead to infection or other complications if the device is not properly cleaned after use.

Who’s affected

Healthcare professionals using Olympus endoscopes with the MAJ-891 model are most at risk. Patients using these devices may face infection if biomaterial is not fully removed during cleaning.

How to tell if you have this one

Check for model number MAJ-891 on the device. All units sold by Olympus Corporation of the Americas are affected. The UDI-DI number is 04953170063114.

  • Brand
    Olympus
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Look for model number MAJ-891 on the forceps or irrigation plug.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 35 days after the firm started it.

1. Firm started the recall: Dec 18, 202412. FDA classified it Class I: Jan 16, 202523. Published in FDA’s Enforcement Report: Jan 22, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Is this product safe to use?

The product is safe if reprocessed correctly. Inadequate disassembly during reprocessing may retain biomaterial.

Similar recalls

Latest medical device recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0905-2025 (December 18, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0905-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA