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Compass Health Brands (Corporate Office) Recalls
9 recalls on record · August 29, 2018 to April 26, 2023 · Medical Devices
Recalls by year
18
19
22
23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 26, 2023Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ach
Hazard: 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
January 26, 2022Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager
Hazard: Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
May 22, 2019Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
Hazard: Product design change did not receive proper premarket clearance and lacks a 510 (k)
May 22, 2019Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
Hazard: Product design change did not receive proper premarket clearance and lacks a 510 (k)
May 22, 2019Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
Hazard: Product design change did not receive proper premarket clearance and lacks a 510 (k)
May 22, 2019Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
Hazard: Product design change did not receive proper premarket clearance and lacks a 510 (k)
May 22, 2019Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
Hazard: Product design change did not receive proper premarket clearance and lacks a 510 (k)
May 22, 2019Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
Hazard: Product design change did not receive proper premarket clearance and lacks a 510 (k)
August 29, 2018Medical DevicesFDA
Compass Health Brands (Corporate Office) recalls CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to
Hazard: A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customers may not be aware of the incompatibility.