FDA Device recall Z-2831-2018
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography
- FDA Device
- Class II
- terminated
- Published 2018-08-22
On 2018-08-22 the FDA classified a Class II recall of S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography by Beekley, citing there is a potential for imaging artifact to mimic calcifications on patient's mammograms.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2831-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-06-13 |
| Published | 2018-08-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Beekley |
| Distribution | US |
Product
S-SPOT REF 777, 777S Adhere to skin for marking and identifying moles in mammography.
Reason
There is a potential for imaging artifact to mimic calcifications on patient's mammograms
Identifiers
| code_info | REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281…REF 777 - Lot Numbers: 02281802 05301801 04041801 04211801 03301801 05101802 05241801 02191801 03151801 03281801 04281801 02131802 REF 777S - Lot Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2831-2018%22
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