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Lower risk Medical device recall · FDA · Published January 29, 2026

Olympus Single Use Biopsy Valve Recall: Risk of Rubber Fragments Detaching

Olympus recalls 20-unit boxes of MAJ-210 biopsy valves due to potential rubber fragment detachment during use. Affected units sold with UDI-DI numbers 14953170152433 and 1495:14953170452069.

🇺🇸 FDA recall #Z-1488-2026Medical deviceOlympus ›
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Recalling firmOlympus Corporation of the Americas3500 Corporate Pkwy · Center Valley, PA 18034-8229
✎ GovInfoNow plain-language explainer

Olympus is recalling single-use biopsy valves (model MAJ-210) because rubber parts might detach during use. This could cause injury if fragments enter the body. The recall affects 20 valves per box sold with specific UDI-DI numbers. Read more at govinfonow.com/recall/50072-olympus-single-use-biopsy-valve-recall-risk-of-rubber-fragments.

Source Summary by GovInfoNow · govinfonow.com/recall/50072-olympus-single-use-biopsy-valve-recall-risk-of-rubber-fragments · Updated August 10, 2026 · FDA enforcement record: FDA #Z-1488-2026

Cite this page

“Olympus Single Use Biopsy Valve Recall: Risk of Rubber Fragments Detaching.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/50072-olympus-single-use-biopsy-valve-recall-risk-of-rubber-fragments. Based on FDA recall #Z-1488-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1488-2026%22&limit=1).

The FDA announced on Jan. 29, 2026, that Olympus Corporation of the Americas is recalling its Single use Biopsy Valve, model MAJ-210, due to the potential for rubber fragment detachment during use. The agency classified this as a Class II recall affecting 95,882 boxes distributed nationwide.

How to tell if you have it

  • Brand: Olympus
  • Product: Single use Biopsy Valve
  • Model/Catalog Number: MAJ-210
  • UDI-DI: 14953170152433, 14953170452069
  • Lot Numbers: All Lot Numbers
  • Quantity: 20 units per box

The hazard

The recall addresses the potential for rubber fragment detachment during use of the Olympus Single use Biopsy Valve. The device is designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.

Context

GovInfoNow's records show Olympus Corporation of the Americas has 133 other recalls on record since Aug. 18, 2017. Other recent recalls include an Olympus Tripp-Lite P580-025 DisplayPort Cable (Aug. 27, 2026), an Olympus M3 Gold Autoclavable Foroblique Telescope (Aug. 24, 2026), and a BiCOAG Hemostasis Probe 7Fr Connector (Aug. 19, 2026). On Feb. 16, 2026, Medline recalled convenience kits with Olympus biopsy valves due to the risk of foreign body in the patient airway.

How to tell if you have this one

Check for the model number MAJ-210 on the valve packaging. Look for UDI-DI numbers 14953170152433 or 14953170452069 on the valve's label. These valves come in boxes of 20 units.

  • Brand
    Olympus
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-1488-2026Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.; Model/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box.95,882 boxes (20 per box)
Z-1489-2026Olympus Single Use Biopsy Valve. Model/Catalog Number: MAJ-1218. 20 units per box. The MAJ-1218 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent leakage of body fluids.; Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.1,276 boxes (20 units per box)
Based on the official FDA remedy

What to do — step by step

  1. Check Valve Label

    Look for the model number MAJ-210 and UDI-DI numbers 14953170152433 or 14953170452069 on the valve's label.

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 41 days after the firm started it.

1. Firm started the recall: Jan 29, 202612. FDA classified it Class II: Mar 3, 202623. Published in FDA’s Enforcement Report: Mar 11, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

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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-1488-2026 (January 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1488-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 10, 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