Facility

Spark Biomedical Inc.

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

Key facts

1recalls · 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)	3017987352
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device; Complaint File Establishment per 21 CFR 820.198
Location	7535 W Grand Pkwy S Richmond, TX, US 77407
Registration status	Active · expires 2026
Parent company	Spark Biomedical Inc (owner-operator 10080441)
Brand names	Sparrow Ascent

Activity by year

Recalls (1)

Devices registered here (1)

Percutaneous Nerve Stimulator For Opioid Withdrawal
Product code PZR (opens in a new tab) · Class II · Neurology · 21 CFR 882.5896

Recalls & enforcement

Class IIOngoing2025-07-02
Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output.

All facilities operated by Spark 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. “Spark Biomedical Inc. (FEI 3017987352) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3017987352-spark-biomedical-inc/

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