Drug recall
50-GEL20; Ultrasound gel
FDA recall event 92735 · Class II · Advance Medical Designs, Inc.
Key facts
| Event ID | 92735 |
|---|---|
| Recall numbers | Z-2532-2023, Z-2533-2023, Z-2534-2023, Z-2535-2023, Z-2536-2023, Z-2537-2023 |
| Recalling firm | Advance Medical Designs, Inc. |
| Product type | Devices |
| Products | 50-GEL20; Ultrasound gel, ASG-001; Ultrasound gel, Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648, Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04, 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 and 1 more |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Ultrasound gel mislabeled with inappropriate use. |
| Initiation date | Jul 7, 2023 |
| Report date | Sep 20, 2023 |
| City | Marietta |
| State | GA |
| Country | United States |
| FEI number | 1037885 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: