Facility

ALLISON MEDICAL, INC.

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

Key facts

2recalls · 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)	1000138447
Establishment type	Complaint File Establishment per 21 CFR 820.198
Location	8091 Shaffer Pkwy Littleton, CO, US 80127
Registration status	Active · expires 2026
Parent company	ALLISON MEDICAL, INC. (owner-operator 9009434)

Activity by year

Recalls (2)
Inspections (3)

Devices registered here (1)

Needle, Hypodermic, Single Lumen
Product code FMI (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5570

Recalls & enforcement

Class IICompleted2020-09-03
Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic but its effect on drug potency or interaction is unknown.
Class IICompleted2018-01-19
Insulin syringe retail packages incorrectly labeled as "Short Needle".

FDA inspections (3)

NAI2023-04-28
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-07-29
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2016-10-12
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 ALLISON MEDICAL, 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. “ALLISON MEDICAL, INC. (FEI 1000138447) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000138447-allison-medical-inc/

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