FDA Device recall Z-2535-2023
Procedural kits containing ultrasonic transmission gel, Item Numbers: a) 20-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
- 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-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648 by Advance Medical Designs, citing ultrasound gel mislabeled with inappropriate use.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2535-2023 |
| 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-PC424, b) 20-PC448, c) 20-PC548, d) 20-PC596, e) 20-PC648
Reason
Ultrasound gel mislabeled with inappropriate use.
Identifiers
| code_info | a) 20-PC424, Lot Numbers: 21109C2345; b) 20-PC448, Lot Numbers: 30371C3276; c) 20-PC548, Lot Numbers: 21088C2341,…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 |
|---|
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-2535-2023%22
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