Lower riskMedical device recall · FDA · Published March 7, 2023
Compass Health REX Pressure Therapy System Recall: Manual Error May Mislead DVT Use
Compass Health recalls REX Pressure Therapy System user manuals due to an error indicating DVT prevention without proper FDA approval. This may lead to unsafe use of the device for deep vein thrombosis prevention.
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
Take action
Contact the company
📍Recalling firmCompass Health Brands (Corporate Office)6753 Engle Rd · Middleburg Heights, OH 44130-7934
“Compass Health REX Pressure Therapy System Recall: Manual Error May Mislead DVT Use.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58784-compass-health-rex-pressure-therapy-system-recall-manual-error-may. Based on FDA recall #Z-1398-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1398-2023%22&limit=1).
The FDA announced on March 7, 2023, that Compass Health Brands is recalling the REX (Recovery Exercise X-Trainer) Pressure Therapy System user manual. The recall addresses an error indicating the device may prevent deep vein thrombosis, a use for which it was marketed without clearance.
How to tell if you have it
Brand: Compass Health
Product: REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual
Models: DVTREX-U and DVTREX -L
UDI-DI (DVTREX-L): 00092237622933
UDI-DI (DVTREX-U): 00092237622926
Quantity: 30 units
The hazard
The user manual contains an error in the Introduction section that indicates the device may be used for the prevention of deep vein thrombosis (DVT). The device was marketed without a 510(k) clearance for this specific indication.
Context
GovInfoNow's records show Compass Health Brands has issued three other recalls since June 18, 2018, including a Voyager Rollator recall on Jan. 10, 2022, and a MediPress Full Leg Compression System recall on April 8, 2019. Other recent recalls of similar products include the Boston Scientific ENROUTE Transcarotid Neuroprotection System recall (July 9, 2026), the Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray recall (Nov. 6, 2025), and the INSPIREMD CGuard Prime Carotid Stent System recall (May 1, 2026).
How to tell if you have this one
Check for the DVTREX-U or DVTREX-L models with serial numbers starting with 00092237622926 or 00092237622933. All units produced are affected.
Brand
Compass Health
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Review User Manual
Check if the manual contains the error about DVT prevention without FDA approval.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1398-2023 (March 7, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1398-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.