FDA Device recall Z-2534-2023
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
- FDA Device
- Class II
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class II recall of Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04 by Advance Medical Designs, citing ultrasound gel mislabeled with inappropriate use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2534-2023 |
| 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
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PMT03, b) 20PMT04
Reason
Ultrasound gel mislabeled with inappropriate use.
Identifiers
| code_info | a) 20-PMT03, Lot Numbers: 30479C3299 b) 20-PMT04, Lot Numbers: 30394C3279 |
|---|
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-2534-2023%22
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