Z-0159-2020Class II

Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System -

Name: Z-0159-2020 Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System -
Creator: Olympus Corporation of the Americas
Published: 2019-09-12
License: https://open.fda.gov/license/

OLYMPUS Corporation of the Americas / initiated 2019-09-12 / Open, Classified / root cause: manufacturing process

FDA source

Olympus Corporation of the Americas began a recall of Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System - Product Usage: designed for rapid transcervical aspiration of the uterine cavity... on 2019-09-12. FDA classified it as Class II and gives the reason as "Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the filter cartridge, thus the housing could separate". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0159-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-09-12
Posted: 2019-10-17
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
Product code: HHI System, Abortion, Vacuum
Reason for recall: 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 tag: manufacturing process
FDA 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 [email protected] for any additional information concerning this matter.
Quantity in commerce: 1106 boxes (10 filters/box)
Distribution: US Nationwide distribution.
Product codes and lots: Lot number: 494604

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0159-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0159-2020	Class II	Ongoing	Voluntary: Firm initiated	2019-10-23	2019-10-17

Product code HHI

K030935Class IIBerkeley V-10 Vacuum Curettage SystemAcmi Corporation / cleared 2003-06-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)