Recall archive / FDA device enforcement
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enable... — FDA record Z-1753-2025
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Apr 9, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
- Reason
- The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When this failure occurs, the capacitor may produce smoke and a burning smell. In extremely rare instances a capacitor may cause a spark or excessive heat when an internal capacitor failure occurs.
- Classification
- Class II
- Recalling firm
- Richard Wolf GmbH
- Quantity
- 31 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1753-2025
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI-DI: 00814334022863; 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US State: GA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- May 21, 2025
- Recall initiation date
- Apr 9, 2025
- Center classification date
- May 13, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.