Pressure Therapy System Recalled for Unauthorized Deep Vein Thrombosis Prevention Claim
Compass Health Brands is recalling the REX Pressure Therapy System because the user manual incorrectly claims the device can prevent deep vein thrombosis, an indication for which the device was not FDA-cleared.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a labeling error in the user manual claiming an unauthorized medical indication without required FDA 510k approval. No injuries or illnesses have been reported, and the hazard is limited to the documentation error.
Plain-English summary
Compass Health Brands is recalling the REX (Recovery Exercise X-Trainer) Pressure Therapy System, models DVTREX-U and DVTREX-L. The device is intended to temporarily relieve minor muscle aches and pains and to temporarily increase circulation to treated areas.
The recall is due to an error in the Introduction section of the device's user manual. The manual incorrectly indicates that the device may be used for the prevention of deep vein thrombosis (DVT), an indication for which the device was not cleared by the FDA via 510k approval. This represents an unauthorized marketing claim for a regulated indication.
Approximately 30 units have been distributed worldwide, including throughout the United States and Canada. The affected units are identified by UDI-DI codes DVTREX-L 00092237622933 and DVTREX-U 00092237622926, covering all serial numbers for both models.
The recalled product
- 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
- Manufacturer
- Compass Health Brands (Corporate Office)
- Hazard
- mis-labeling
- unauthorized-indication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers
Distribution
Distributed nationwide across the United States.
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