REX — Class II medical device recall Z-1398-2023
Ongoing recall by Compass Health Brands (Corporate Office), reported 2023-04-26, distributed nationwide. Error in the Introduction section of the user manual that indicates the device may be used for the prevention
| Recall number | Z-1398-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Compass Health Brands (Corporate Office), Middleburg Heights, OH, United States |
| Recall initiated | 2023-03-07 |
| Classified | 2023-04-18 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 30 units |
| UPC / GTIN / UDI-DI | 00092237622926, 00092237622933 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1398-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.