Facility

GENESEE BIOMEDICAL, INC.

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

Key facts

1recalls · worst Class II

1inspections · 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)	1000517719
Establishment type	Manufacture Medical Device
Location	700 W Mississippi Ave Unit D5 DENVER, CO, US 80223
Registration status	Active · expires 2026
Parent company	GENESEE BIOMEDICAL, INC. (owner-operator 9012312)
Brand names	FlexForm Annuloplasty Ring & FlexForm Annuloplasty Band

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Ring, Annuloplasty
Product code KRH (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.3800

Recalls & enforcement

Class IIOngoing2018-02-26
Failure in a retractor blade due to corrosion. In the area of the blade where the bearing/button meets the blade body, corrosion can form, weakening the welded joint and may cause the bearing/button to break.

FDA inspections (1)

VAI2018-02-09
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.

All facilities operated by GENESEE BIOMEDICAL, 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. “GENESEE BIOMEDICAL, INC. (FEI 1000517719) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000517719-genesee-biomedical-inc/

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