Reported Sep 20, 2023 · Ongoing

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

Advance Medical Designs, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advance Medical Designs, Inc. · 1241 Atlanta Industrial Dr · Marietta, GA · 30066-6606

Is this the product you have?

  • Procedural kits containing ultrasonic transmission gel
  • Item Numbers
    • a) 20-PMT03
    • b) 20PMT04
Lot codes and dates
  • a) 20-PMT03
  • Lot Numbers30479C3299 b) 20-PMT04
  • Lot Numbers30394C3279
Amount recalled
26900 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Why it was recalled

Ultrasound gel mislabeled with inappropriate use.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:39 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.