BEMER INT. AG: Medical Device Recall in 2021 - (Recall #: Z-1105-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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)

Product Classification:

Class II

Date Initiated: January 13, 2021

Date Posted: February 17, 2021

Recall Number: Z-1105-2021

Event ID: 87094

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.

Status: Terminated

Product Quantity: 197,724 units

Code Information:

All Lot Numbers

Distribution Pattern:

Voluntary or Mandated:

Voluntary: Firm initiated