Facility

DIVERSATEK HEALTHCARE INC.

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

Key facts

2recalls · 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)	2023374
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	9150 Commerce Center Cir Ste 500 Highlands Ranch, CO, US 80129
Registration status	Active · expires 2026
Parent company	DIVERSATEK HEALTHCARE (owner-operator 2023374)

Activity by year

Recalls (2)

Devices registered here (1)

Electrode, Ph, Stomach
Product code FFT (opens in a new tab) · Class I · Gastroenterology, Urology · 21 CFR 876.1400

Recalls & enforcement

Class IIIOngoing2025-06-04
Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
Class IIIOngoing2023-07-25
GI Software labelled as revision 3.3.0 is incorrectly labeled and is in fact revision 3.2.0.

All facilities operated by DIVERSATEK HEALTHCARE

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. “DIVERSATEK HEALTHCARE INC. (FEI 2023374) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2023374-diversatek-healthcare-inc/

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