# FDA recall Z-1398-2023

> **Compass Health Brands (Corporate Office)** · Class II · device recall initiated 2023-03-07.

## 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

## Reason for recall

Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-1398-2023
- **Recalling firm:** Compass Health Brands (Corporate Office)
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-07
- **Report date:** 2023-04-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Middleburg Heights, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1398-2023

## Citation

> AI Analytics. FDA recall Z-1398-2023. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1398-2023. Source: US FDA. Licensed CC0.

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