ASG-001 ultrasound gel recalled for mislabeling regarding use instructions
Advance Medical Designs is recalling ASG-001 ultrasound gel due to mislabeling of use instructions. The product was distributed in the US, Canada, UK, Panama, and Netherlands.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a labeling error regarding use instructions, which creates a theoretical risk of misuse rather than documented harm.
Plain-English summary
Advance Medical Designs, Inc. is recalling ASG-001, an ultrasound gel used in medical applications. The recall was initiated due to the product being mislabeled with inappropriate use instructions.
The product was distributed in the United States, Canada, United Kingdom, Panama, and the Netherlands. Consumers and healthcare providers who have this product should discontinue use and contact the manufacturer for instructions regarding return or replacement.
No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- ASG-001; Ultrasound gel
- Manufacturer
- Advance Medical Designs, Inc.
- Category
- Medical Device — Ultrasound gel
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Not individually distributed
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Advance Medical Designs, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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