RICHMAR REX - UNIVERSAL DVTREX-URecalls & reported problems
Drive Devilbiss Healthcare · REX DVT System-Universal Pump, LE Garments & Backpack · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Recalls naming this device
- Mar 7, 2023Open, Classified
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
Z-1398-2023 · Root cause: Labeling design · Recall details · FDA record ↗
Other Massager, Powered Inflatable Tube devices
- RICHMAR REX - LARGE DVTREX-LDrive Devilbiss Healthcare · Massager, Powered Inflatable Tube1 recall0 reports
- HOMEDICS SR-160HJFka Distributing CO., LLC · Massager, Powered Inflatable Tube1 recall0 reports
- NormaTec Normatec 3 / REJ6 / Leg SystemNormatec Industries LP · Massager, Powered Inflatable Tube8 reports
- Game Ready GRPRO 2.1 Control Unit Rental 550550-03-RNAvanos Medical, Inc. · Massager, powered inflatable tube2 reports
- Game Ready 590424-03-RNAvanos Medical, Inc. · Massager, powered inflatable tube1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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