Facility

Bradshaw Medical Inc.

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

Key facts

1recalls · worst Class II

4inspections · worst VAI

—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)	3006846753
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	10325 58th Place Kenosha, WI, US 53144
Registration status	Active · expires 2026
Parent company	Bradshaw Medical Inc. (owner-operator 10025925)

Activity by year

Recalls (1)
Inspections (4)

Devices registered here (1)

Appliance, Fixation, Spinal Intervertebral Body
Product code KWQ (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3060

Recalls & enforcement

Class IITerminated2015-02-02
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.

FDA inspections (4)

NAI2025-09-12
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2022-02-28
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
VAI2017-08-15
Voluntary Action Indicated · Compliance: Devices · citations posted
VAI2016-04-11
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

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 Bradshaw 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. “Bradshaw Medical Inc. (FEI 3006846753) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006846753-bradshaw-medical-inc/

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