Device recall

Z-0306-2025: DeRoyal C-SECTION TRACEPACK, REF 89-9338-06

FDA device recall · Class II · DeRoyal Industries Inc

Key facts

Recall number (Z-number) Z-0306-2025
Recall event 95509
Product DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Product code KDD
Recalling firm DeRoyal Industries Inc
Recall class Class II
Status Open, Classified
FEI number 1043214

At a glance

  • None Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)