Class II

Medical Device Recall: PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).

Richard Wolf GmbH · April 9, 2025

Reason for Recall

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.

Distribution

US State: GA

States Affected

GA

Quantity Affected

31 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1753-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Richard Wolf GmbH Medical Device Recall: PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager). | SafeCheck