Facility

ALLOSOURCE

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

Key facts

1recalls · worst Class II

3inspections · 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)	3000215346
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	6278 S Troy Circle Centennial, CO, US 80111
Registration status	Active · expires 2026
Parent company	AlloSource (owner-operator 10025681)

Activity by year

Recalls (1)
Inspections (3)

Devices registered here (1)

Mesh, Surgical
Product code FTM (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.3300

Recalls & enforcement

Class IITerminated2014-03-25
The donor was hemodiluted.

FDA inspections (3)

VAI2022-07-27
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2018-12-18
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-02-09
Voluntary Action Indicated · Compliance: 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 AlloSource

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. “ALLOSOURCE (FEI 3000215346) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000215346-allosource/

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