O-SPOT recall
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Why was O-SPOT recalled?
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF 791 - Lot Numbers: 05311802 03051802 03271802 04191801 04031801 04241801 04231801 03291802 04021801 02271801 05291802 03081801 03091801 05111801 05251801 04091801 02201801 02231801 02071801 02091801 03161802 03231801 02131801 05031801 03011801 03291801 04301801 05171801 04161801 04261801 02051801 04051801 03201801 03221801 02151801 03221802 02021801 05231802 05021801 04191802 05291801 04301802 05211802 02191802 REF 791S - Lot Numbers: 03191801 02221802
- Product
- O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
- Recalling firm
- Beekley Corporation
- Quantity
- 3,384,024 pieces in total.
- Distribution
- Worldwide Distribution: US (Nationwide) and countries of; AUSTRALIA, AUSTRIA, BAHRAIN, CANADA, GREAT BRITAIN, ISRAEL, SAUDI ARABIA, SOUTH AFRICA & UNITED ARAB EMIRATES.
- Recall date
- August 22, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)