# FDA recall Z-0705-2020

> **Bio-Signal Group Corp.** · Class II · device recall initiated 2019-10-29.

## 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)

## Distribution

US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.

## Key facts

- **Recall number:** Z-0705-2020
- **Recalling firm:** Bio-Signal Group Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-10-29
- **Report date:** 2019-12-25
- **Termination date:** 2021-09-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Acton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2020

## Citation

> AI Analytics. FDA recall Z-0705-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0705-2020. Source: US FDA. Licensed CC0.

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