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Unrated Medical device recall · FDA · Published January 13, 2021

BEMER Pro-Set and B.BOX Professional devices may interfere with insulin pumps

BEMER recalls specific models of electromagnetic therapy devices due to potential interference with insulin pumps and pacemakers. Affected models include BEMER Pro-Set and B.BOX Professional series. No remedy is stated in the recall notice.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1105-2021Medical deviceBEMER ›
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Recalling firmBEMER INT. AGAustrasse 15 · Triesen, Liechtenstein
✎ GovInfoNow plain-language explainer

BEMER is recalling specific electromagnetic therapy devices that could interfere with insulin pumps or pacemakers. This poses a risk for people using medical devices that rely on electronic signals. Read more at govinfonow.com/recall/63427-bemer-pro-set-and-b-box-professional-devices-may-interfere.

Source Summary by GovInfoNow · govinfonow.com/recall/63427-bemer-pro-set-and-b-box-professional-devices-may-interfere · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1105-2021

Cite this page

“BEMER Pro-Set and B.BOX Professional devices may interfere with insulin pumps.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63427-bemer-pro-set-and-b-box-professional-devices-may-interfere. Based on FDA recall #Z-1105-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1105-2021%22&limit=1).

BEMER INT. AG recalled Bemer-Set/ Pro-Set therapy systems on Jan. 13, 2021, according to the FDA. The devices may cause technical defects in insulin pumps or pacemaker malfunctions due to generated electromagnetic fields.

How to tell if you have it

  • Brand: BEMER
  • Models: REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), REF. 420100 (B.BOX CLASSIC), REF. 410100 (BEMER Classic-Set), REF. 420200, REF. 410200 (BEMER Pro - Set)
  • Lot Numbers: All Lot Numbers
  • Quantity: 197,724 units

The hazard

The FDA stated there is a potential that electromagnetic fields generated in the therapy system may cause technical defects in a patient using an insulin pump or a malfunction of a pacemaker.

Context

GovInfoNow's records show other recent recalls include Elekta Medical Linear Accelerators (2025-12-14) and Medtronic MiniMed 640G Insulin Pump Recall (2026-07-13). Additional similar product recalls listed are the Medtronic MiniMed 780G Insulin Pump Recall dated 2026-07-13.

How to tell if you have this one

Check for model numbers REF. 410201 (BEMER Pro-Set), REF. 420201 (B.BOX Professional), or REF. 420100 (B.BOX CLASSIC). These devices were sold with all lot numbers.

  • Brand
    BEMER
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Identify your device model by checking the label on the device or its packaging.

How this recall unfolded

Recall timeline

FDA terminated this recall 2.5 years after the firm started it.

1. Firm started the recall: Jan 13, 202112. FDA classified it Class II: Feb 10, 202123. Published in FDA’s Enforcement Report: Feb 17, 202134. FDA terminated the recall: Jul 12, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1105-2021 (January 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1105-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA