Device recall

Z-2533-2023: 50-GEL20; Ultrasound gel

FDA device recall · Class II · Advance Medical Designs, Inc.

Key facts

Recall number (Z-number) Z-2533-2023
Recall event 92735
Product 50-GEL20; Ultrasound gel
Product code MUI
Recalling firm Advance Medical Designs, Inc.
Recall class Class II
Status Open, Classified
510(k) numbers K130581
FEI number 1037885

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 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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