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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
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.
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 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
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.
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 Updated User Manual for Replacement Cushion Seal