Field Correction Recall of USER MANUAL for REX (Recovery Exercise Trainer) - March 2023

Products: USER MANUAL for REX (Recovery Exercise Trainer)

Models: DVTREX-U and DVTREX -L


Affected Serial Numbers: All

A voluntary Field Correction recall is being initiated by Compass Health Brands for the USER MANUAL for the REX (Recovery Exercise Trainer) Pressure Therapy System (Model Number: DVTREX-U and DVTREX -L).

Reason for Field Correction: Compass Health Brands has recently identified an error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). This model of the compression system is not designed or FDA-cleared for this indication for use. To date, Compass Health Brands has received 0 customer complaints for this error, and 0 injuries.

Download the Distributor Recall Details

Download the End User/Consumer Recall Details

Download REPLACEMENT USER MANUAL

Voyager Rollator Recall – January 2022

Products: Voyager Rollator

Models: RLEU10PK, RLEU10BL, RLEU10WT

Affected Serial Numbers: All

Compass Health Brands is voluntarily recalling these rollators because the wheel spoke could crack causing the wheel to separate from the axle and potentially result in bruising or minor lacerations due to falls.

Download the Retailer/Distributor Recall Details

Download the End User/Consumer Recall Details

ProBasics Voyager Front and Rear Wheel Replacement Video

Adult Portable Bed Rail Recall – December 2021

Products: Bed Support Rail and Easy Up Bed Rail

Models: P566 and P569

Affected Serial Numbers: All

Compass Health Brands is voluntarily recalling these bed rails because users can become entrapped within the bed rail or between the rail and side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxia

Download the Recall Details

Click for P566 Replacement Kit Installation Video

Medical Device Recall – April 2019

Products: MediPress Segmental Garments (Lymphedema Sleeves) – accessories for MediPress Pneumatic Compression Lymphedema Pump

Models: #6102-S (half leg), #6103L-S (full leg – Long), #6103M-S (full leg - Medium), #6103S-S (full leg – Short), #6104M-S (full arm - Medium), #6104S-S (full arm – Short)

Affected Serial Numbers: All

Compass Health Brands Corp. is issuing a voluntary recall for the items listed above after it was discovered that a design change did not receive proper premarket clearance as required by Section 510(k) of the Food, Drug, and Cosmetic Act.

Download the Recall Details

Medical Device Field Correction – June 2018

Products: Instructions for Use for REPLACEMENT CUSHION SEALS for Probasics Brand Zzz-Mask SG Full Face CPAP Mask

Models: PB781S, PB781M, PB781L, 781S, 781M and 781L Manufactured After May 2015

Compass Health Brands Corp. has recently identified the need to clarify compatibility information for the replacement cushion seals for the Model# PB7801 Zzz-Mask SG Series Full Face CPAP Mask.

Download the Recall Details

Download the Updated User Manual for Replacement Cushion Seal

Voyager Rollator Recall – January 2022

Products: Voyager Rollator

Models: RLEU10PK, RLEU10BL, RLEU10WT

Affected Serial Numbers: All

Compass Health Brands is voluntarily recalling these rollators because the wheel spoke could crack causing the wheel to separate from the axle and potentially result in bruising or minor lacerations due to falls.

Download the Retailer/Distributor Recall Details

Download the End User/Consumer Recall Details

Adult Portable Bed Rail Recall – December 2021

Products: Bed Support Rail and Easy Up Bed Rail

Models: P566 and P569

Affected Serial Numbers: All

Compass Health Brands is voluntarily recalling these bed rails because users can become entrapped within the bed rail or between the rail and side of the mattress. This poses a serious entrapment hazard and risk of death by asphyxia

Download the Recall Details

Click for P566 Replacement Kit Installation Video

Medical Device Recall – April 2019

Products: MediPress Segmental Garments (Lymphedema Sleeves) – accessories for MediPress Pneumatic Compression Lymphedema Pump

Models: #6102-S (half leg), #6103L-S (full leg – Long), #6103M-S (full leg - Medium), #6103S-S (full leg – Short), #6104M-S (full arm - Medium), #6104S-S (full arm – Short)

Affected Serial Numbers: All

Compass Health Brands Corp. is issuing a voluntary recall for the items listed above after it was discovered that a design change did not receive proper premarket clearance as required by Section 510(k) of the Food, Drug, and Cosmetic Act.

Download the Recall Details

Medical Device Field Correction – June 2018

Products: Instructions for Use for REPLACEMENT CUSHION SEALS for Probasics Brand Zzz-Mask SG Full Face CPAP Mask

Models: PB781S, PB781M, PB781L, 781S, 781M and 781L Manufactured After May 2015

Compass Health Brands Corp. has recently identified the need to clarify compatibility information for the replacement cushion seals for the Model# PB7801 Zzz-Mask SG Series Full Face CPAP Mask.

Download the Recall Details

Download the Updated User Manual for Replacement Cushion Seal