Compass Health Brands (Corporate Office)

United Statesfrom the FDA registration address FDA establishment FEI 3012316249

Devices: 0
Registrations: FDA
FDA recalls: 92 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number: 3012316249
Address: 6753 Engle Rd, Middleburg Heights, OH, 44130

FDA recalls9

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

Recalls initiated per year

2017 0
2018 1
2019 6
2020 0
2021 0
2022 1
2023 1
2024 0
2025 0
2026 0

2023
- 7 Mar 2023 Z-1398-2023 Class II Ongoing 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. Submission number: K192358
2022
- 10 Jan 2022 Z-0510-2022 Class II Ongoing 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
2019
- 8 Apr 2019 Z-1343-2019 Class II Terminated 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,…
  Full distribution text
  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
  Submission number: K974393
- 8 Apr 2019 Z-1344-2019 Class II Terminated 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,…
  Full distribution text
  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
  Submission number: K974393
- 8 Apr 2019 Z-1345-2019 Class II Terminated 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,…
  Full distribution text
  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
  Submission number: K974393
- 8 Apr 2019 Z-1346-2019 Class II Terminated 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,…
  Full distribution text
  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
  Submission number: K974393
- 8 Apr 2019 Z-1347-2019 Class II Terminated 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,…
  Full distribution text
  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
  Submission number: K974393
- 8 Apr 2019 Z-1348-2019 Class II Terminated 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,…
  Full distribution text
  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
  Submission number: K974393
2018
- 18 Jun 2018 Z-2741-2018 Class I Terminated 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. Submission number: K063268

This is an FDA establishment record without devices in deviCERTS.