Device recall

Z-2250-2024: Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product…

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

Key facts

Recall number (Z-number) Z-2250-2024
Recall event 94837
Product Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients…
Product code GEI
Recalling firm Megadyne Medical Products, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K031285
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)