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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

Richard Wolf PiezoWave 2 Therapy Devices Recalled for Fire and Smoke Risk

Agency Publication Date: May 13, 2025
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Summary

Richard Wolf GmbH has recalled approximately 31 PiezoWave 2 Control Units (Product Number 100506US), which are compact therapy devices used for piezoelectric shockwave treatments. The recall was issued because a high-voltage component inside the device can fail early in its lifespan, causing smoke, a burning smell, and in rare cases, sparks or extreme heat. These devices were specifically distributed in Georgia, and no injuries or incidents have been reported to date.

Risk

A component failure within the control unit can cause the device to overheat, smoke, or spark during use. This poses a potential fire hazard and a risk of burn injuries to both the operator and the patient.

What You Should Do

  1. This recall affects the Richard Wolf PiezoWave 2 Control Unit (Product Number 100506US), a therapeutic massager used for acoustic compression therapy, with UDI-DI 00814334022863.
  2. Identify if your device is included in the recall by checking the serial number printed on the device label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device immediately. Contact Richard Wolf GmbH or your authorized distributor to arrange for the return, replacement, or correction of the unit.
  4. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information regarding medical device recalls.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: PiezoWave 2 Control Unit
Model / REF:
100506US
Serial Numbers:
5000553232
5000553233
5000553234
5000553235
5000553236
5000553237
5000553238
5000553239
5000553240
5000553241
5000553242
5000553243
5000553244
5000553245
5000553246
5000553247
5000553248
5000553249
5000553250
5000553251
5000553482
5000553483
5000553484
5000553485
5000553486
5000553488
5000553502
5000553503
5000553504
5000553505
5000553506
UDI:
00814334022863

Therapeutic massager enabling treatment with piezoelectric shockwaves.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96692
Status: Active
Manufacturer: Richard Wolf GmbH
Sold By: Authorized distributors; Richard Wolf GmbH
Manufactured In: Germany
Units Affected: 31 units
Distributed To: Georgia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.