Facility

SYNAPSE BIOMEDICAL INC.

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

Key facts

2recalls · worst Class I

2inspections · worst OAI

—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)	3005868392
Establishment type	Complaint File Establishment per 21 CFR 820.198; Manufacture Medical Device
Location	300 Artino Street Oberlin, OH, US 44074
Registration status	Active · expires 2026
Parent company	Synapse Biomedical Inc. (owner-operator 10024968)
Brand names	NeuRx DPS; NeuRx Diaphragm Pacing System

Activity by year

Recalls (2)
Inspections (2)

Devices registered here (1)

Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator
Product code OIR (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class ITerminated2022-07-11
Due to a defect identified on the EPG controller printed circuit board assembly, device performance may degrade over time. Depending on the failure mode, potential adverse events include pain, muscle fatigue and decreased breathing effectiveness, arrhythmia or cardiac arrest, or …
Class IIITerminated2022-05-31
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport conditions or tolerance conditions for the package material).

FDA inspections (2)

NAI2023-01-18
No Action Indicated · Postmarket Assurance: Devices
OAI2020-10-07
Official Action Indicated · 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 Synapse 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. “SYNAPSE BIOMEDICAL INC. (FEI 3005868392) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3005868392-synapse-biomedical-inc/

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