Facility

CHECKPOINT SURGICAL 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)	3045522387
Establishment type	Develop Specifications But Do Not Manufacture At This Facility
Location	6650 W Snowville Rd Ste I Brecksville, OH, US 44141
Registration status	Active · expires 2026
Parent company	Checkpoint Surgical Inc. (owner-operator 10053637)
Brand names	Checkpoint Stimulator

Activity by year

Recalls (1)

Devices registered here (1)

Stimulator, Nerve
Product code ETN (opens in a new tab) · Class II · Ear, Nose, Throat · 21 CFR 874.1820

Recalls & enforcement

Class IIOngoing2025-02-24
Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compr…

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. “CHECKPOINT SURGICAL INC. (FEI 3045522387) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3045522387-checkpoint-surgical-inc/

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