Facility

FIREFLY MEDICAL, INC.

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

Key facts

2recalls · worst Class II

—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)	3011390406
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	320 E Vine Dr Ste 315 Fort Collins, CO, US 80524
Registration status	Active · expires 2026
Parent company	FIREFLY MEDICAL, INC. (owner-operator 10048720)
Brand names	IVEA MODEL 600A; IVEA; IVEA MODEL 500A; IVEA MODEL 600S; IVEA O2 Tank Booster Accessory

Activity by year

Recalls (2)

Devices registered here (1)

Stand, Infusion
Product code FOX (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6990

Recalls & enforcement

Class IITerminated2017-08-24
The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding cycles (designed for easy storage) of the IVEA unit.
Class IITerminated2016-11-01
The dowel pin could potentially slip out of its press fit, resulting in the product potentially slumping to one side which could cause the patient to stumble.

All facilities operated by FIREFLY 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. “FIREFLY MEDICAL, INC. (FEI 3011390406) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011390406-firefly-medical-inc/

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