Procedural kits containing ultrasonic transmission gel, I... (Advance Medical Designs, Inc.) – mislabeling (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Brand
Advance Medical Designs, Inc.
Lot Codes / Batch Numbers
a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279
Products Sold
a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279
Advance Medical Designs, Inc. is recalling Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 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