The Recall Desk
HighFDA (Devices)·Z-1105-2021·Announced 2021-02-17

BEMER Therapy Systems Recalled for Potential Interference with Pacemakers and Insulin Pumps

BEMER International AG is recalling Bemer-Set and Pro-Set therapy systems because electromagnetic fields may cause technical defects in insulin pumps or pacemaker malfunctions.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (interference with life-sustaining medical devices like pacemakers and insulin pumps) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

BEMER International AG is recalling Bemer-Set and Pro-Set therapy systems, including the BEMER Pro-Set, B.BOX Professional, B.BOX CLASSIC, and BEMER Classic-Set models. The recall covers 197,724 units distributed in the United States.

The recall was issued because there is a potential that electromagnetic fields generated by the therapy system may cause technical defects in a patient using an insulin pump or a malfunction of a pacemaker. The source text does not report any specific injuries, illnesses, or deaths associated with this hazard.

Consumers using these devices should stop using them and contact BEMER International AG for instructions on how to proceed. The recall applies to all lot numbers for the specified models.

The recalled product

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)
Manufacturer
BEMER INT. AG
Category
Medical Device — Therapy Systems
Hazard
Affected units
197,724

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lot Numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

Same hazard · electromagnetic interference

See all →