Device recall

Z-1398-2023: REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended…

FDA device recall · Class II · Compass Health Brands (Corporate Office)

Key facts

Recall number (Z-number) Z-1398-2023
Recall event 91923
Product REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L
Product code IRP
Recalling firm Compass Health Brands (Corporate Office)
Recall class Class II
Status Open, Classified
510(k) numbers K192358
FEI number 3012316249

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

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