Device recall

Z-0977-2020: Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867…

FDA device recall · Class II · Cook Inc.

Key facts

Recall number (Z-number) Z-0977-2020
Recall event 82026
Product Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
Product code FAD
Recalling firm Cook Inc.
Recall class Class II
Status Terminated
Termination date May 29, 2020
510(k) numbers K961446
FEI number 1820334

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 Products in the same recall event
  • 10–99 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)