The Recall Desk
ModerateFDA (Devices)·Z-2111-2012·Announced 2012-08-08

Beekley O-Spots Floral Skin Markers Recalled for Separation Defect

Beekley Corporation is recalling 267,332 units of O-Spots Floral Skin Markers because the digital skin marker may separate from the backing material.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations or injuries, fitting the criteria for a moderate severity score involving a defect without reported harm.

Plain-English summary

Beekley Corporation is recalling 267,332 units of Beekley O-Spots Floral Skin Markers, Order Number 752. These products are used as mammography skin markers to mark moles, scars, palpable masses, or areas of concern. The recall was initiated because the digital skin mammography marker may separate from the backing of the spot material.

The affected units were distributed nationwide in the United States. The recall covers specific lot numbers: A036, A037, A038, A039, A040, A041, A042, A044, A045, and A046. The U.S. Food and Drug Administration has classified this as a Class II recall.

Consumers and healthcare facilities should stop using the affected products and contact Beekley Corporation for further instructions or a return.

The recalled product

Product
Beekley O-Spots Floral Skin Markers -Order Number: 752 Product Usage: Mammography Skin Markers for marking: moles, scars, palpable masses or areas of concern
Manufacturer
Beekley Corporation
Category
Medical Device — Mammography Skin Markers
Hazard
Affected units
267,332

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (10)

  • Lot Numbers: A036
  • A037
  • A038
  • A039
  • A040
  • A041
  • A042
  • A044
  • A045
  • A046

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Beekley Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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