Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be at
FDA device recall Z-1488-2026 · posted 2026-03-03 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for rubber fragment detachment during use.
- Action taken
- Olympus notified consignees on about 01/29/2026 via letter titled URGENT: FIELD SAFETY NOTICE. Consignees were instructed to carefully read the content of the notification, ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification, and that they may continue using the devices as per the notification and instructions for use. Olympus is highlighting the importance of strictly adhering to the Inspection of the Biopsy Valve and Inserting and Withdrawing the Endo-therapy accessories sections in the IFU related to the detachment of fragment from the slit part of rubber. Consignees were requested to acknowledge receipt of the notification via their portal and if product has been further distributed to notify those consignees.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- EOQ
- Quantity affected
- 95,882 boxes (20 per box)
- Distribution
- US Nationwide distribution.
- Date initiated
- 2026-01-29
- Date posted
- 2026-03-03
- Location
- Center Valley, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EVIS EXERA 180 SYSTEM (K061313) | Olympus Medical Systems Corporation | 2006-08-31 |