HydroDot brand: Wave Prep Single use cups — Class II medical device recall Z-0705-2020
Terminated recall by Bio-Signal Group Corp., reported 2019-12-25, distributed nationwide. Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
| Recall number | Z-0705-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bio-Signal Group Corp., Acton, MA, United States |
| Recall initiated | 2019-10-29 |
| Classified | 2019-12-18 |
| Reported by FDA | 2019-12-25 |
| Terminated | 2021-09-07 |
| Distributed | Nationwide (US) |
| Pathogens | burkholderia |
| Lot numbers | 29879, 29958, 30656, 31320, 31365 |
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 for recall
Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0705-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.