Class II — BEMER INT. AG
| Recalling firm | BEMER Int. AG |
|---|---|
| Registered facility | BEMER Int. AG (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | There potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pumps or a malfunction of a pacemaker. |
| Product | Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200 (B.BOX Professional), and REF. 410200 (BEMER Pro - Set) |
| Quantity | 197,724 units |
| Distribution | US |
| Initiated | 2021-01-13 |
| Classified | 2021-02-10 |
| Terminated | 2023-07-12 |
| Recall number | Z-1105-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BEMER INT. AG (Z-1105-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/87094/
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