FDA Medical devices recall ·
Olympus Single use Biopsy Valve recall
- Recall number
- Z-1488-2026
- Date
- (initiated January 29, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 95,882 boxes (20 per box)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus 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.
Why was it recalled?
Potential for rubber fragment detachment during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: MAJ-210. UDI-DI: 14953170152433, 14953170452069. All Lot Numbers. 20 units per box.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1488-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.