Z-1398-2023Class II

REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor...

Name: Z-1398-2023 REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor...
Creator: Compass Health Brands (Corporate Office)
Published: 2023-03-07
License: https://open.fda.gov/license/

Compass Health Brands (Corporate Office) / initiated 2023-03-07 / Open, Classified / root cause: labeling and UDI

FDA source

Compass Health Brands (Corporate Office) began a recall of REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily... on 2023-03-07. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1398-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-03-07
Posted: 2023-04-18
Recalling firm: Compass Health Brands (Corporate Office)
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
Product code: IRP Massager, Powered Inflatable Tube
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
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Compass Health Brands issued Urgent Medical Device Recall Letter REX (Recovery Exercise Trainer) Pressure Therapy System - USER MANUAL on 3/7/23 via Email/US Mail notification to Distributors and End Users consignees and posted to the Compass Health Brands website http://www.compasshealthbrands.com. Letter states reason for recall, health risk and action to take: Immediately replace the current user manual included with the device with the attached, corrected version, and dispose of the current manual. Compass Health Brands will additionally mail you a replacement user Consumer Notification manual in booklet format (which is the same format as the current user manual), if you prefer to use that as a replacement, instead. REQUIRED ACTION: 1. The USER MANUAL for the REX (Recovery Exercise Trainer) Pressure Therapy System requires replacement. Visit https://compasshealthbrands.com/product-recall to obtain a replacement user manual, or Contact Compass Health Brands at (800) 947-1728 to order a replacement user manual in booklet format, or Indicate on your Reply Form (attached) that you would like a replacement user manual. 2. Complete and return the attached Consumer Field Correction Response Form to Compass Health Brands within fifteen (15) calendar days of receipt of this field correction notification confirming your acknowledgement. Send completed form to Compass Health Brands via email at [email protected]. Complete and return this form even if you do not have affected product on hand. If you have transferred possession of this product to another individual/department/location, please notify them of this recall communication. This voluntary Field Correction notification is being conducted with the knowledge of the United States Food and Drug Administration (FDA) in accordance with U.S. regulations. Any complaints and/or adverse events experienced with the use of this product must be reported promptly to Compass Health Brands Customer Suppor
Quantity in commerce: 30 units
Distribution: Worldwide distribution - US Nationwide and the country of Canada.
Product codes and lots: UDI-DI: DVTREX-L: 00092237622933 DVTREX-U: 00092237622926 All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1398-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1398-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-26	2023-04-18

Product code IRP

K192358Class IIPressure Therapy System PT1003Xiamen Senyang Co., Ltd. / cleared 2020-04-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)