PiezoWave 2 Control Unit — Class II medical device recall Z-1753-2025
Ongoing recall by Richard Wolf GmbH, reported 2025-05-21. The high voltage capacitor may fail early in the product life cycle after delivery of surge voltages. When thi
| Recall number | Z-1753-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard Wolf GmbH, Knittlingen, Germany |
| Recall initiated | 2025-04-09 |
| Classified | 2025-05-13 |
| Reported by FDA | 2025-05-21 |
| Quantity | 31 units |
| Reason classes | device malfunction |
| UPC / GTIN / 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 and 6 more |
Product
PiezoWave 2 Control Unit, Product Number 100506US, compact myofascial acoustic compression therapy device that enables treatment with piezoelectric shockwaves (Therapeutic massager).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1753-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.