VariaBreeze — Class II medical device recall Z-2915-2016
Terminated recall by New Star Lasers, Inc., reported 2016-10-12. FDA inspection found that customers who had received devices with promotional material with outside use indica
| Recall number | Z-2915-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | New Star Lasers, Inc., Roseville, CA, United States |
| Recall initiated | 2016-09-19 |
| Classified | 2016-09-30 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2016-12-13 |
| Quantity | 17 systems |
| Reason classes | labeling |
| Serial numbers | AESB01, AHSF02, AHSF03, AHSF04, AHSF05, AHSF06, AHSF07, AHSF08, AHTE01, AHTF01, AHTF02, AHTH01, AHTM01, AHTM02, AHTS01, AHTS03, XSB02-VB |
| Model numbers | 7300-0035-2 |
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 for recall
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.
Machine access
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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.