CLASS II Device recall · Reported 17 Feb 2021 · FDA Enforcement Report
Bemer-Set/ Pro-Set for the following recalled by Bemer Int. Ag
Bemer Int. Ag is recalling Bemer-Set/ Pro-Set for the following. The recall was initiated on 13 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1105-2021
- FDA event ID
- 87094
- Recalling firm
- Bemer Int. Ag, Triesen, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2021
- FDA classified
- 10 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 13 Jan 2021 | Recall initiated by company | |
| 10 Feb 2021 | Classified by FDA | +28 days |
| 17 Feb 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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)
Where it was distributed
US
Questions about this recall
Is Bemer-Set/ Pro-Set for the following recalled?
Yes. Bemer Int. Ag recalled Bemer-Set/ Pro-Set for the following on 13 Jan 2021. The recall is Class II and its status is Terminated. Recall number Z-1105-2021.
Why was it recalled?
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.
Which lots are affected?
All Lot Numbers
Where was it sold?
US
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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