FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
- Recall number
- Z-0159-2020
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity. Part# 54298-10/pack
- Status
- Open, Classified
- Initiated
- 2019-09-12
- Posted
- not on file
- Terminated
- not on file
- Reason
- Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
- Root cause
- Process control
- Action
- Olympus issued notification letter on 9/12/19 via Federal Express two day delivery stating reason for recall, health risk and action to take: 1. Immediately assess any affected product you have in stock, remove it from your inventory and quarantine it until it is shipped back to us. 2.Call your Olympus customer service representative at 1-888-524-7266 option 1. Olympus will issue a Return Material Authorization in order to return any affected product at no charge to you. Olympus will issue a credit or replacement to your facility for your affected product.. 4.Fax the completed Reply form to Olympus Market Quality at 484-896-7128 regardless of whether you have any affected inventory at your facility. Contact 484-896-5688 or at laura.storms@olympus.com for any additional information concerning this matter.
- Quantity
- 1106 boxes (10 filters/box)
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Lot number: 494604
- 510(k) numbers
- ["K030935"]
- PMA numbers
- not on file
- Product code
- HHI
- 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