Device recall

Z-1105-2021: Bemer-Set/ Pro-Set for the following models: REF. 410201 (BEMER Pro-Set), REF…

FDA device recall · Class II · BEMER INT. AG

Key facts

Recall number (Z-number) Z-1105-2021
Recall event 87094
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)
Product code NGX
Recalling firm BEMER INT. AG
Recall class Class II
Status Terminated
Termination date Jul 12, 2023
510(k) numbers K151834
FEI number 3009102830

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

Browse all FDA device recalls (products)