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
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
Lot number: 494604
Products Sold
Lot number: 494604
Olympus Corporation of the Americas is recalling Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed f due to Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026