O-SPOT REF 791 — Class II medical device recall Z-2830-2018
Terminated recall by Beekley Corporation, reported 2018-08-22, distributed nationwide. There is a potential for imaging artifact to mimic calcifications on patient's mammograms
| Recall number | Z-2830-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Beekley Corporation, Bristol, CT, United States |
| Recall initiated | 2018-06-13 |
| Classified | 2018-08-16 |
| Reported by FDA | 2018-08-22 |
| Terminated | 2018-11-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BH, CA, GB, IL, SA, ZA |
| Quantity | 3,384,024 units |
| Lot numbers | 02021801, 02051801, 02071801, 02091801, 02131801, 02151801, 02191802, 02201801, 02221802, 02231801, 02271801, 03011801, 03051802, 03081801, 03091801, 03161802, 03191801, 03201801, 03221801, 03221802, 03231801, 03271802, 03291801, 03291802, 04021801, 04031801, 04051801, 04091801, 04161801, 04191801, 04191802, 04231801, 04241801, 04261801, 04301801, 04301802, 05021801, 05031801, 05111801, 05171801 and 6 more |
| Model numbers | 791, 791S |
Product
O-SPOT REF 791, 791S Adhere to skin for marking and identifying moles in mammography.
Reason for recall
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2830-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.