Device recall

Z-2175-2025: Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash…

FDA device recall · Class II · Remote Diagnostic Technologies Ltd.

Key facts

Recall number (Z-number) Z-2175-2025
Recall event 97197
Product Inseego USB8 4G Dongle Kit, Part Number: 01-2298, which contains USB Flash Drive, Part Number: 43-2011. The kit is an accessory to the Tempus Pro Monitor, REF: 00-1007-R, 00-1024-R, 00-1026-R
Product code MHX
Recalling firm Remote Diagnostic Technologies Ltd.
Recall class Class II
Status Open, Classified
510(k) numbers K201746
FEI number 3003832357

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 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)