CLASS II Device recall · Reported 25 Dec 2019 · FDA Enforcement Report

HydroDot Wave Prep Single use cups, 8.5 gm 24/box-Product recalled

Bio-Signal Group is recalling HydroDot Wave Prep Single use cups, 8.5 gm 24/box-Product 1700-24, distributed nationwide in the US. The recall was initiated on 29 Oct 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365

Quantity recalled45,375 individual cups Expanded:1314 boxes (24/box)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0705-2020
FDA event ID: 84305
Recalling firm: Bio-Signal Group, Acton, MA
Classification: Class II
Status: Terminated
Recall initiated: 29 Oct 2019
FDA classified: 18 Dec 2019
Reported: 25 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

29 Oct 2019	Recall initiated by company
18 Dec 2019	Classified by FDA	+50 days
25 Dec 2019	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide California Kentucky Massachusetts New Mexico Pennsylvania Wisconsin

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 84305

This product is part of a recall event; the main page for the event is HydroDot Wave Prep tubes-Product recalled by Bio-Signal Group.

Reported	Class	Recall	Company	Reason	Where
25 Dec 2019	CLASS II	HydroDot Wave Prep tubes-Product recalled by Bio-Signal Group	Bio-Signal Group	Sterility	Nationwide

More recalls from Bio-Signal Group

All 2

Reported	Class	Recall	Company	Reason	Where
25 Dec 2019Device	CLASS II	HydroDot Wave Prep tubes-Product recalled by Bio-Signal Group	Bio-Signal Group	Sterility	Nationwide

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