Bemer-Set/ Pro-Set for the following models: REF — Class II medical device recall Z-1105-2021
Terminated recall by BEMER INT. AG, reported 2021-02-17. There potential that electromagnetic fields generated in the therapy system may cause technical defects in a p
| Recall number | Z-1105-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | BEMER INT. AG, Triesen, N/A, Liechtenstein |
| Recall initiated | 2021-01-13 |
| Classified | 2021-02-10 |
| Reported by FDA | 2021-02-17 |
| Terminated | 2023-07-12 |
| Quantity | 197,724 units |
| Reason classes | device malfunction |
| Model numbers | 410100, 410200, 410201, 420100, 420200, 420201 |
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)
Reason for recall
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.
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-1105-2021. 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.