FDA Device recall Z-2830-2018
O-SPOT REF 791, 791S 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 O-SPOT REF 791, 791S 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-2830-2018 |
| 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
O-SPOT REF 791, 791S 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 791 - Lot Numbers: 05311802 03051802 03271802 04191801 04031801 04241801 04231801 03291802 04021801 02271…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 |
|---|
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-2830-2018%22
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