Device recall

Z-0159-2020: Berkeley Disposa-Filter used with Berkeley VC-10 Vacuum Curettage System…

FDA device recall · Class II · Olympus Corporation of the Americas

Key facts

Recall number (Z-number) Z-0159-2020
Recall event 83826
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
Recalling firm Olympus Corporation of the Americas
Recall class Class II
Status Open, Classified
510(k) numbers K030935
FEI number 2429304

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)