Facility

OAKWORKS, INC.

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

Key facts

5recalls · worst Class II

2inspections · 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)	1000121370
Establishment type	Manufacture Medical Device
Location	923 E Wellspring Rd NEW FREEDOM, PA, US 17349
Registration status	Active · expires 2026
Parent company	Oakworks, INC. (owner-operator 9004167)
Brand names	Carbon Fiber Arm Board 3" Pad; Carbon Fiber Arm Board 2 Pad; Carbon Fiber Arm Board 1 Pad; Patient (Restraint) Strap

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Table, Radiographic, Stationary Top
Product code IXQ (opens in a new tab) · Class II · Radiology · 21 CFR 892.1980

Recalls & enforcement

Class IIOngoing2023-12-05
Backrest platform stress fracture - the table is not operational in an inclined position
Class IITerminated2022-04-21
The warning label was printed with the incorrect weight capacity. The correct weight limit is 400 lbs., but the label states 500 lbs.
Class IITerminated2021-06-29
Weld failure- the bracket attaches the tabletop tilting actuator to the tabletop frame. If the bracket weld fails, the tabletop tilting action is non-functional
Class IITerminated2019-05-02
Table assembly error with incorrect actuators for the lateral and longitudinal table movements
Class IITerminated2017-07-31
The foot control used on the OAKWORKS® Inc., CFPM300, CFPM301, CFPM400, CFPM401, CFPMB301, CFUR301, CFUR401 and CFLU401 Imaging Tables can become lodged under the base or under the column of the table.

FDA inspections (2)

VAI2024-01-17
Voluntary Action Indicated · Compliance: Devices; Radiation Control and Health Safety Act; Postmarket Assurance: Devices · citations posted
VAI2017-03-16
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 Oakworks, 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. “OAKWORKS, INC. (FEI 1000121370) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000121370-oakworks-inc/

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