Compass Health Brands (Corporate Office) recalls REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle…
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
Read the official notice →- Date
- 2023-04-26
- Country
- United States
- Brand
- Compass Health Brands
- Product
- REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the country of Canada.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Compass Health Brands recalls
- 2022-01-26
USCompass Health Brands (Corporate Office) recalls Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager…
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
- 2021-12-22
- US
Compass Health Brands Recalls Carex Adult Portable Bed Rails After Three Deaths; Entrapment and Asphyxiation Hazards
When attached to an adult's bed, users can become entrapped within the bed rail or between the rail and the side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxiation.
Other drugs & medical recalls in the United States
- 2023-04-26
- US
Avanos Medical, Inc. recalls Avanos Ballard Oral Care Swab, Bulk Packed, Product Codes: a) 12241, b) 12243, c) 12251
Incorrect expiration date.
FDA · DeviceAvanos Medical, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Germany,…Official notice → - US
Medacta Usa Inc recalls MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device
There is a potential for breakage of the small screw used to affix the anti-backout plate.
- US
Tobii Dynavox Llc recalls Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device used for ambulatory people with disabilities. Catalog #: 750567
Problem maintaining the stable placement of the battery may come loose from the housing and become damaged.
FDA · DeviceTobii Dynavox LlcWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Boston Scientific Corporation recalls Habib EndoHPB Bipolar Radiofrequency (RF) Catheter 8F (2.7mm). A radiofrequency (RF) catheter which provides bipolar energy to…
Cease use of the Habib EndoHPB Bipolar RF Catheter with the ERBE VIO3 Generator immediately due to the potential for delivery of excessive energy leading to thermal injury or tissue damage. An inaccurate setting is…
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody Calibrators programmed onto the Assay Data Disks (ADD) Data…
Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), resulting in delayed patients results
FDA · DeviceOrtho-Clinical Diagnostics, Inc.US Nationwide distribution in the states of AL, AZ, CA, GA, NY.Official notice → - US
GRAMERCY EXTREMITY ORTHOPEDICS recalls GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
Instrument Kits for EPS plates may contain drill guides with incorrect drill depth range of 30mm - 60mm; not the correct drill depth range of 10mm - 40mm.
FDA · DeviceGRAMERCY EXTREMITY ORTHOPEDICSUS Nationwide distribution in the states of CT, OR, NJ, AZ, CT, OH, AZ.Official notice →