FDA Medical devices recall ·
PiezoWave 2 Control Unit, Product Number 100506US… recall
- Recall number
- Z-1753-2025
- Date
- (initiated April 9, 2025)
- Company / brand
- Richard Wolf GmbH
Pforzheimer Str. 32, Knittlingen, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 31 units
- Hazard tags
- Burn
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
US State: GA
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1753-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.