FDA Device recall Z-2915-2016
VariaBreeze
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of VariaBreeze by New Star Lasers, citing FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these ind….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2915-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-09-19 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | New Star Lasers |
| Distribution | n/a |
Product
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Reason
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
Identifiers
| code_info | Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03. |
|---|
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-2915-2016%22
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