Device recall

Z-0971-2020: Urethral Dilator Set, Global Product No. G14185

FDA device recall · Class II · Cook Inc.

Key facts

Recall number (Z-number) Z-0971-2020
Recall event 82026
Product Urethral Dilator Set, Global Product No. G14185
Product code KOE
Recalling firm Cook Inc.
Recall class Class II
Status Terminated
Termination date May 29, 2020
510(k) numbers K811833
FEI number 1820334

At a glance

  • 1–9 Linked 510(k)s
  • 10–99 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)