Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HydroDot brand: Wave Prep Single use cups Recalled by Bio-Signal Group Corp. Due to Product has the potential to be contaminated with...

Date: October 29, 2019
Company: Bio-Signal Group Corp.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bio-Signal Group Corp. directly.

Affected Products

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.

Quantity: 45,375 individual cups Expanded:1314 boxes (24/box)

Why Was This Recalled?

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Bio-Signal Group Corp.

Bio-Signal Group Corp. has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report