PlainRecalls
ModerateClass IITerminated

FDA Devices recall · Reported August 8, 2012

Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

Digital Skin Mammography Marker separating from the backing of the spot material

Recall #
Z-2111-2012
Affected scope
267,332 units
Initiated
July 9, 2012
Verify with FDA Devices →
View my saved recalls

Beekley Corporation recalled Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Ski… - a moderate-severity action.

Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Ski… was recalled by Beekley Corporation in August 8, 2012. Reason: Digital Skin Mammography Marker separating from the backing of the spot material. Check the official notice for the remedy. Verify recall #Z-2111-2012 with the FDA Devices before acting.

The recall

Beekley Corporation issued this moderate-severity FDA Devices recall-Digital Skin Mammography Marker separating from the backing of the spot material.

Moderate
severity level
267K units
affected scope
Class II
classification
August 8, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2111-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope (see the Recall Profile below) is large enough to require multi-state distribution tracking. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Medical Devices recalls over time

Where this recall sits in its category - 41,021 medical devices recalls on record

01,0002,0003,0004,000 20052008201120142017202020232026 1,947
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern

Reason for recall

Digital Skin Mammography Marker separating from the backing of the spot material

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-2111-2012
Date reported August 8, 2012
Date initiated July 9, 2012
Recalling firm Beekley Corporation
Firm location Bristol, CT
Affected scope 267,332 units
Distribution US Nationwide Distribution

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

267,332 units units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (Z-2111-2012) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Devices before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern. Recalled by Beekley Corporation. Units affected: 267,332 units.
Why was this product recalled?
Digital Skin Mammography Marker separating from the backing of the spot material
Which agency issued this recall?
This recall was issued by the FDA Devices on August 8, 2012. Severity: Moderate. Recall number: Z-2111-2012.
Where was the recalled product distributed?
Distribution: US Nationwide Distribution.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported August 8, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026