FDA Device recall Z-0705-2020
HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with…
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with… by Bio Signal Group, citing product has the potential to be contaminated with Burkholderia cepacia (B. cepacia).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0705-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-29 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bio Signal Group |
| Distribution | US |
Product
HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.
Reason
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Identifiers
| code_info | Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0705-2020%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.