50-GEL20; Ultrasound gel (Advance Medical Designs, Inc.) – mislabeling (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
50-GEL20; Ultrasound gel
Brand
Advance Medical Designs, Inc.
Lot Codes / Batch Numbers
Lot Number 21043C2328
Products Sold
Lot Number 21043C2328
Advance Medical Designs, Inc. is recalling 50-GEL20; Ultrasound gel due to Ultrasound gel mislabeled with inappropriate use.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Ultrasound gel mislabeled with inappropriate use.
Recommended Action
Per FDA guidance
Advance Medical Designs issued an URGENT MEDICAL DEVICE RECALL notice on 07/27/2023 by email and USPS, first class. The notice explained the problem, hazard, and requested the consignee locate, isolate, and cease all use of the affected products. Distributors were directed to notify their customers. Advance Medical Designs is seeking the return of the affected products.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026