Reported Feb 17, 2021 · Terminated

Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100…

Bemer Int. Ag

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: BEMER INT. AG · Austrasse 15 · Triesen, N/A · N/A

Is this the product you have?

  • 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)
Lot codes and dates
  • All Lot Numbers
Amount recalled
197,724 units

Why it was 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 12, 2023 · Data as of Sep 19, 5:42 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.