Facility

HOME HEALTH US INCORPORATED

1 recall(s) on record — most severe on record: Class III.

Key facts

1recalls · worst Class III

—inspections in our data

—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)	3021186226
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	7672 15th St E Sarasota, FL, US 34243
Registration status	Active · expires 2026
Parent company	Home Health US Inc (owner-operator 10083434)
Brand names	One Step®

Activity by year

Recalls (1)

Devices registered here (1)

Enzymatic Esterase--Oxidase, Cholesterol
Product code CHH (opens in a new tab) · Class I · Clinical Chemistry · 21 CFR 862.1175

Recalls & enforcement

Class IIIOngoing2025-07-25
Due to incorrect/lack of Unique Device Identifier (UDI) codes.

All facilities operated by Home Health US Inc

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. “HOME HEALTH US INCORPORATED (FEI 3021186226) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3021186226-home-health-us-incorporated/

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