Facility

COMPASS HEALTH BRANDS (CORPORATE OFFICE)

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

Key facts

5recalls · worst Class I

2inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012316249
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	6753 Engle Rd Middleburg Heights, OH, US 44130
Registration status	Active · expires 2026
Parent company	Compass Health Brands (Corporate Office) (owner-operator 2182780)

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Massager, Powered Inflatable Tube
Product code IRP (opens in a new tab) · Class II · Physical Medicine · 21 CFR 890.5650

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…

FDA inspections (2)

VAI2022-12-19
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2021-10-07
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “COMPASS HEALTH BRANDS (CORPORATE OFFICE) (FEI 3012316249) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012316249-compass-health-brands-corporate-office/

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