Device recall

Z-1920-2024: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return…

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

Key facts

Recall number (Z-number) Z-1920-2024
Recall event 94544
Product MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
Product code GEI
Recalling firm Megadyne Medical Products, Inc.
Recall class Class I
Status Open, Classified
510(k) numbers K080741
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

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