Facility

LINEAGE BIOMEDICAL, INC

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

Key facts

1recalls · worst Class III

1inspections · worst NAI

—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)	3030201489
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility
Location	620 NW Dixie Hwy Stuart, FL, US 34994
Registration status	Active · expires 2026
Parent company	Lineage Biomedical, Inc (owner-operator 10089727)
Brand names	NavaClick Syringe and Needle; NavaClick Injection System

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (3)

Syringe, Piston
Product code FMF (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5860
Set, I.V. Fluid Transfer
Product code LHI (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5440
Needle, Hypodermic, Single Lumen
Product code FMI (opens in a new tab) · Class II · General Hospital · 21 CFR 880.5570

Recalls & enforcement

Class IIIOngoing2024-07-12
Incorrect GTIN number on carton.

FDA inspections (1)

NAI2025-05-08
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

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 Lineage 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. “LINEAGE BIOMEDICAL, INC (FEI 3030201489) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3030201489-lineage-biomedical-inc/

Not open yet

Alerts for LINEAGE BIOMEDICAL, INC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.