• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Advance

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
  Class 2 Device Recall Advance see related information
Date Initiated by Firm July 07, 2023
Date Posted September 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-2534-2023
Recall Event ID 92735
Product Classification Transducer, ultrasonic, diagnostic - Product Code ITX
Product Procedural kits containing ultrasonic transmission gel, Item Numbers:
a) 20-PMT03, b) 20PMT04
Code Information a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279
Recalling Firm/
Advance Medical Designs, Inc.
1241 Atlanta Industrial Dr
Marietta GA 30066-6606
For Additional Information Contact Carrie Farmer
Manufacturer Reason
for Recall
Ultrasound gel mislabeled with inappropriate use.
FDA Determined
Cause 2
Action 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.
Quantity in Commerce 26900 units
Distribution US, Canada, UK, Panama, Netherlands
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.