Food, drugs, devices › Beekley Corporation
Device recall: Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammogr
FDA enforcement event 65483 is a device recall by Beekley Corporation of Bristol, CT, initiated 19 Jun 2013 and classified Class III, with 1 product record.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,236 device enforcement events initiated in 2013 carry the same class.
Status: Terminated, terminated 16 Jun 2014. Initiation: voluntary: firm initiated. Beekley Corporation has 5 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Beekley Corporation, Bristol, CT.
Reason for recall
"Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots"
Distribution
"Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1787-2014 | Beekley Spots Light Image O-Spots for Mammography Catalog Number: 252 Product Usage: To identify raised moles in Mammography | 81 boxes | Class III | Terminated | 18 Jun 2014 |
Context
Other enforcement events for Beekley Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 13 Jun 2018 | O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography. | Device | Class II | 3 |
| 8 May 2017 | Beekley Medical 0-SPOT Mammography Skin Markers REF 652 | Device | Class III | 1 |
| 9 Jul 2012 | Beekley S-Spots Floral Skin Markers -Order Number: 750 Product Usage: Mammography Skin Markers for marking: moles, scars | Device | Class II | 4 |
| 2 Jul 2012 | Bella Blanket Protective Coverlet, for Mammography, 18cm x 25cm or 24cm x 30cm, Product Code: 311. The purpose of the pr | Device | Class II | 1 |
All 5 events for Beekley Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots"
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide Distribution - USA in the states of CA, FL, MA, NC, NY, and PA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 16 Jun 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.