Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage… — Class II medical device recall Z-0159-2020
Ongoing recall by Olympus Corporation of the Americas, reported 2019-10-23, distributed nationwide. Berkeley Disposa-Filter may possess an insufficient ultrasonic weld defect which joins the two-halves of the f
| Recall number | Z-0159-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Olympus Corporation of the Americas, Center Valley, PA, United States |
| Recall initiated | 2019-09-12 |
| Classified | 2019-10-17 |
| Reported by FDA | 2019-10-23 |
| Distributed | Nationwide (US) |
| Lot numbers | 494604 |
| Model numbers | 54298-10/PACK |
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
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0159-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.