Reported Aug 22, 2018 · Terminated
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Beekley Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beekley Corporation · 1 Prestige Ln · Bristol, CT · 06010-7468
Is this the product you have?
- O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
- Lot codes and dates
4 of 4 products
Products covered by this recall Model / number Product as published 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 791S— — Lot Numbers: 03191801 02221802 - Amount recalled
- 3,384,024 pieces in total.
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Beekley Corporation recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.