Advance Medical Designs, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2534-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04

Product Classification:

Class II

Date Initiated: July 7, 2023

Date Posted: September 20, 2023

Recall Number: Z-2534-2023

Event ID: 92735

Reason for Recall:

Ultrasound gel mislabeled with inappropriate use.

Status: Ongoing

Product Quantity: 26900 units

Code Information:

a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279

Distribution Pattern:

US, Canada, UK, Panama, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated