FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus 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.
- Recall number
- Z-1489-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus 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.
- Status
- Open, Classified
- Initiated
- 2026-01-29
- Posted
- 2026-03-03
- Terminated
- not on file
- Reason
- Potential for rubber fragment detachment during use.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 1,276 boxes (20 units per box)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model/Catalog Number: MAJ-1218. UDI-DI: 14953170154291. All Lot Numbers. 20 units per box.
- 510(k) numbers
- ["K061313"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28