CLASS III Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

Medical 0-SPOT Mammography Skin Markers recalled by Beekley

Beekley is recalling Beekley Medical 0-SPOT Mammography Skin Markers, distributed nationwide in the US. The recall was initiated on 8 May 2017 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLOT 652.04251701

Quantity recalled104 boxes (58/box)= 6,032 total units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2309-2017
FDA event ID: 77295
Recalling firm: Beekley, Bristol, CT
Classification: Class III
Status: Terminated
Recall initiated: 8 May 2017
FDA classified: 7 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

8 May 2017	Recall initiated by company
7 Jun 2017	Classified by FDA	+30 days
14 Jun 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

Product as listed by the FDA

Beekley Medical 0-SPOT Mammography Skin Markers REF 652

Where it was distributed

US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.

Nationwide Arkansas California Georgia Illinois Minnesota Nevada New York Texas Wisconsin

Questions about this recall

Is Medical 0-SPOT Mammography Skin Markers recalled?

Yes. Beekley recalled Medical 0-SPOT Mammography Skin Markers on 8 May 2017. The recall is Class III and its status is Terminated. Recall number Z-2309-2017.

Why was it recalled?

Mammography Skin Marker 0 -SPOT (REF 652) product was mis-labeled with A-SPOT (REF 651) labels

Which lots are affected?

LOT 652.04251701

Where was it sold?

US Distribution to the states of : AR, CA GA, IL, TX, MN, NV, NY, WI., and Internationally to Canada.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Beekley

All 10

Reported	Class	Recall	Company	Reason	Where
22 Aug 2018Device	CLASS II	O-spot REF 791, 791S Adhere to skin for marking recalled by Beekley	Beekley	Other	Nationwide
22 Aug 2018Device	CLASS II	TomoSPOT REF 782, 782S, 783, 783S, 784, 784S, 785 & 785S Adhere to recalled	Beekley	Other	Nationwide
22 Aug 2018Device	CLASS II	S-spot REF 777, 777S Adhere to skin for marking recalled by Beekley	Beekley	Other	Nationwide
18 Jun 2014Device	CLASS III	Spots Light Image O-Spots for Mammography recalled by Beekley	Beekley	Labeling Errors	6 states
8 Aug 2012Device	CLASS II	O-Spots Floral Skin Markers recalled by Beekley	Beekley	Other	Nationwide

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