FDA Device recall Z-1398-2023
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual by Compass Health Brands Corporate Office, citing 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 indic….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1398-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-07 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Compass Health Brands Corporate Office |
| Distribution | US |
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
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
Identifiers
| code_info | UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1398-2023%22
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