Advance Medical Designs, Inc. is recalling 160,865 units of ultrasound gel and various procedural kits containing the gel because they were mislabeled with inappropriate use instructions. The recall affects specific individual ultrasound gel packets (ASG-001 and 50-GEL20) as well as numerous procedural kits used in medical settings. These products were distributed in the United States, Canada, United Kingdom, Panama, and the Netherlands.
The ultrasound gel is mislabeled for an inappropriate use, which could lead to improper application or medical procedures being performed incorrectly. While no specific injuries were reported, the mislabeling of medical devices poses a risk to patient safety during diagnostic or surgical procedures.
Manufacturer corrective action for mislabeled medical device
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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