Device recall

Z-2349-2024: Cascade IOMAX Cortical Module, REF: 190296-200

FDA device recall · Class II · Cadwell Industries Inc

Key facts

Recall number (Z-number) Z-2349-2024
Recall event 94764
Product Cascade IOMAX Cortical Module, REF: 190296-200
Product code GWF
Recalling firm Cadwell Industries Inc
Recall class Class II
Status Open, Classified
510(k) numbers K162199
FEI number 3020018

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 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)