FDA Device recall Z-2533-2023
50-GEL20
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of 50-GEL20 by Advance Medical Designs, citing ultrasound gel mislabeled with inappropriate use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2533-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-07 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Advance Medical Designs |
| Distribution | n/a |
Product
50-GEL20; Ultrasound gel
Reason
Ultrasound gel mislabeled with inappropriate use.
Identifiers
| code_info | Lot Number 21043C2328 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2533-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.