Middleburg Heights, OH, United States
Compass Health Brands (Corporate Office) recalls
4 recalls recorded since 2018, most recently on 7 March 2023. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)2
Terminated or completed2
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 7 March 2023
- Reason
- 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
- Distribution
- Worldwide distribution - US Nationwide and the country of Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1398-2023
- REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U a
Ongoing Class II Medical devices
- Recall started
- 10 January 2022
- Reason
- Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0510-2022
- Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLE
Terminated Class II Medical devices
- Recall started
- 8 April 2019
- Terminated
- 26 October 2020
- Reason
- Product design change did not receive proper premarket clearance and lacks a 510 (k)
- Distribution
- Domestically to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TN, KY, TX, UT, VA, WA, WI & WY Internationally to Canada
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1343-2019, Z-1347-2019, Z-1344-2019, Z-1346-2019, Z-1348-2019, Z-1345-2019
- MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S
- MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S
- MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S
- MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S
- MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S
- MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S
Terminated Class I Medical devices
- Recall started
- 18 June 2018
- Terminated
- 5 May 2020
- Reason
- 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.
- Distribution
- US nationwide distribution to AL, CT, FL, GA, KY, MS, NC, NY, TN, and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2741-2018
- CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.