Advance Medical Designs, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2535-2023)

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-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648

Product Classification:

Class II

Date Initiated: July 7, 2023

Date Posted: September 20, 2023

Recall Number: Z-2535-2023

Event ID: 92735

Reason for Recall:

Ultrasound gel mislabeled with inappropriate use.

Status: Ongoing

Product Quantity: 117875 units

Code Information:

a) 20-PC424, Lot Numbers: 21109C2345; b) 20-PC448, Lot Numbers: 30371C3276; c) 20-PC548, Lot Numbers: 21088C2341, 30353C3268; d) 20-PC596, Lot Numbers: 20622C2244, 30481C3301; e) 20-PC648, Lot Numbers: 20145C2088, 20163C2097

Distribution Pattern:

US, Canada, UK, Panama, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated