Facility

Beekley Corporation

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)	3000204334
Establishment type	Manufacture Medical Device
Location	1 PRESTIGE LN Bristol, CT, US 06010
Registration status	Active · expires 2026
Parent company	Beekley Corporation (owner-operator 10023165)
Brand names	GuideLines

Activity by year

Recalls (5)
Inspections (2)

Devices registered here (1)

Grid, Radiographic
Product code IXJ (opens in a new tab) · Class I · Radiology · 21 CFR 892.1910

Recalls & enforcement

Class IITerminated2018-06-13
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Class IIITerminated2017-05-08
Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels
Class IIITerminated2013-06-19
Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
Class IITerminated2012-07-09
Digital Skin Mammography Marker separating from the backing of the spot material
Class IITerminated2012-07-02
Imaging artifact can occur on mammogram result

FDA inspections (2)

NAI2025-04-09
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
VAI2018-09-19
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 Beekley Corporation

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. “Beekley Corporation (FEI 3000204334) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000204334-beekley-corporation/

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