Ultrasound gel recalled for mislabeling with inappropriate use instructions
Advance Medical Designs is recalling 50-GEL20 ultrasound gel (13,750 units, lot 21043C2328) due to mislabeling with inappropriate use instructions. The product was distributed in the US, Canada, UK, Panama, and the 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 medical device recall for a labeling defect with inappropriate use instructions. This is classified as a minor labeling error under the severity rubric, warranting a Moderate severity rating.
Plain-English summary
Advance Medical Designs, Inc. is recalling the 50-GEL20 ultrasound gel product due to mislabeling containing inappropriate use instructions. The affected lot number is 21043C2328, representing approximately 13,750 units.
The product was distributed to customers in the United States, Canada, United Kingdom, Panama, and the Netherlands. Healthcare facilities, medical professionals, and other users who received this ultrasound gel should verify whether they have product from the affected lot.
Anyone with the recalled product should discontinue use and contact Advance Medical Designs, Inc. for instructions regarding disposal or replacement of the affected units.
The recalled product
- Product
- 50-GEL20; Ultrasound gel
- Manufacturer
- Advance Medical Designs, Inc.
- Hazard
- Affected units
- 13,750
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)
- Lot Number 21043C2328
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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