FDAClass IISeptember 20, 2023

50-GEL20 recall: Labeling Error

50-GEL20; Ultrasound gel

Why was 50-GEL20 recalled?

Ultrasound gel mislabeled with inappropriate use.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 21043C2328

Product
50-GEL20; Ultrasound gel
Recalling firm
Advance Medical Designs, Inc.
Quantity
13750 units
Distribution
US, Canada, UK, Panama, Netherlands
Recall date
September 20, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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