Device recall

Z-0600-2024: Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return…

FDA device recall · Class I · Megadyne Medical Products, Inc.

Key facts

Recall number (Z-number) Z-0600-2024
Recall event 93597
Product Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Product code GEI
Recalling firm Megadyne Medical Products, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K233644
FEI number 1721194

At a glance

  • 1–9 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)