FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
- Recall number
- Z-3247-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.
- Status
- Open, Classified
- Initiated
- 2026-08-19
- Posted
- 2026-09-18
- Terminated
- not on file
- Reason
- Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
- Root cause
- Nonconforming Material/Component
- Action
- Olumpus notified consignees on 08/19/2026 via "URGENT: MEDICAL DEVICE REMOVAL" letter. Consignees were informed of the reason for recall and hazard involved. Consignees were instructed to examine inventory for affected units, immediately cease use and quarantine them, arrange for their return, and confirm receipt of the recall notification through the portal. Consignees were also instructed to notify customers if product has been further distributed.
- Quantity
- 816 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Latin America, Singapore, Hong Kong, and EU.
- Lot, serial or model codes
- Lot Code: Model: CD-B622LA. UDI-DI: 00821925039452. Lot Numbers: All unexpired lots
- 510(k) numbers
- ["K123319"]
- PMA numbers
- not on file
- Product code
- KNS
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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