S-SPOT REF 777 — Class II medical device recall Z-2831-2018
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-2831-2018 |
|---|---|
| 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 | 02131802, 02191801, 02281802, 03151801, 03281801, 03301801, 04041801, 04211801, 04281801, 05101802, 05241801, 05301801 |
| Model numbers | 777, 777S |
Product
S-SPOT REF 777, 777S 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-2831-2018. 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.