Advance Medical Designs, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2536-2023)

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) 28-EG103, b) 28-EG125, c) 28-EG135, d) 28-EG151, e) 28-EG161, f) 28-EG163, g) 28-EG197

Product Classification:

Class II

Date Initiated: July 7, 2023

Date Posted: September 20, 2023

Recall Number: Z-2536-2023

Event ID: 92735

Reason for Recall:

Ultrasound gel mislabeled with inappropriate use.

Status: Ongoing

Product Quantity: 460 units

Code Information:

a) 28-EG103, Lot Numbers: 10717C1190; b) 28-EG125, Lot Numbers: 30552C3318; c) 28-EG135, Lot Numbers: 10634C1175, 220221C2163; d) 28-EG151, Lot Numbers: 20655C2250, 20814C2279; e) 28-EG161, Lot Numbers: 10759C1198; f) 28-EG163, Lot Numbers: 10614C1166; g) 28-EG197, Lot Numbers: 10710C1190, 20804C2274;

Distribution Pattern:

US, Canada, UK, Panama, Netherlands

Voluntary or Mandated:

Voluntary: Firm initiated