REX (Recovery Exercise X-Trainer) Pressure Therapy recall
REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to…
Why was REX (Recovery Exercise X-Trainer) Pressure Therapy recalled?
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
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers
- Product
- REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to…
- Recalling firm
- Compass Health Brands (Corporate Office)
- Quantity
- 30 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Recall date
- April 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)