Ultrasound Gel Procedural Kits Recalled for Inappropriate Use Mislabeling
Advance Medical Designs is recalling procedural kits containing ultrasonic transmission gel because the product labeling does not accurately indicate appropriate use. The recall affects 460 units distributed to 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: This is an FDA Class II recall involving a labeling issue with no reported illnesses or injuries. The mislabeling creates a potential risk of inappropriate use, which qualifies as moderate severity under the rubric's criteria for labeling errors with theoretical hazard and no reported harm.
Plain-English summary
Advance Medical Designs, Inc. is recalling procedural kits containing ultrasonic transmission gel due to mislabeling regarding appropriate use. The affected products are identified by seven item numbers (28-EG103, 28-EG125, 28-EG135, 28-EG151, 28-EG161, 28-EG163, and 28-EG197), each with specific lot numbers listed in the recall notice.
The recall affects approximately 460 units that have been distributed to the US, Canada, UK, Panama, and Netherlands. The labeling on these kits does not properly indicate the intended use of the product, which could lead to inappropriate application of the ultrasound gel.
Healthcare providers and consumers who have received affected units should verify their product's item number and lot number against the recall notice. Units matching the recalled lot numbers should not be used.
The recalled product
- Product
- Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197
- Manufacturer
- Advance Medical Designs, Inc.
- Category
- Medical Device
- Affected units
- 460
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 (17)
- a) 28-EG103
- Lot Numbers: 10717C1190
- b) 28-EG125
- Lot Numbers: 30552C3318
- c) 28-EG135
- Lot Numbers: 10634C1175
- 220221C2163
- d) 28-EG151
- Lot Numbers: 20655C2250
- 20814C2279
- e) 28-EG161
- Lot Numbers: 10759C1198
- f) 28-EG163
- Lot Numbers: 10614C1166
- g) 28-EG197
- Lot Numbers: 10710C1190
- 20804C2274
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
Same manufacturer · Advance Medical Designs, Inc.
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