RegWardenFDA facility compliance records
Company

Compass Health Brands (Corporate Office)

5 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2015: 1 recalls; 2018: 1 recalls; 2019: 1 recalls; 2022: 1 recalls; 2023: 1 recalls12015201620171201812019202020211202212023202420252026
  • Recalls (5)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2023-03-07
    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
  • Class IIOngoing2022-01-10
    Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
  • Class IITerminated2019-04-08
    Product design change did not receive proper premarket clearance and lacks a 510 (k)
  • Class ITerminated2018-06-18
    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 C…
  • Class IITerminated2015-04-20
    Roscoe Medical has recently identified the need to update its user manual with additional warning statements regarding proper handling and storage of the nebulizer. These warnings are to better inform end users of proper care when using and storing a Roscoe Medical Nebulizer to r…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Compass Health Brands (Corporate Office) — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-2182780-compass-health-brands-corporate-office/

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