CLASS II Device recall · Reported 12 Oct 2016 · FDA Enforcement Report

VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation recalled

New Star Lasers is recalling VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation. The recall was initiated on 19 Sep 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03.

Quantity recalled17 systems

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2915-2016
FDA event ID: 75048
Recalling firm: New Star Lasers, Roseville, CA
Classification: Class II
Status: Terminated
Recall initiated: 19 Sep 2016
FDA classified: 30 Sep 2016
Reported: 12 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Processing Deviation
Device type: Other Medical Devices

Timeline

19 Sep 2016	Recall initiated by company
30 Sep 2016	Classified by FDA	+11 days
12 Oct 2016	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.

Product as listed by the FDA

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.)

Where it was distributed

US distribution only.

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Serial numbers: XSB02-VB AESB01 AHSF02 AHSF04 AHSF05 AHSF06 AHSF07 AHSF08 AHTE01 AHSF03 AHTF01 AHTF02 AHTH01 AHTM02 AHTM01 AHTS01 AHTS03.

Where was it sold?

US distribution only.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 75048

This product is part of a recall event; the main page for the event is ReNew (a.k.a recalled by New Star Lasers.

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016	CLASS II	ReNew (a.k.a recalled by New Star Lasers	New Star Lasers	Processing Deviation	CA
12 Oct 2016	CLASS II	CT3Plus (a.k.a recalled by New Star Lasers	New Star Lasers	Processing Deviation	CA

More recalls from New Star Lasers

All 4

Reported	Class	Recall	Company	Reason	Where
12 Oct 2016Device	CLASS II	CT3Plus (a.k.a recalled by New Star Lasers	New Star Lasers	Processing Deviation	CA
12 Oct 2016Device	CLASS II	ReNew (a.k.a recalled by New Star Lasers	New Star Lasers	Processing Deviation	CA
8 Jul 2015Device	CLASS II	StoneLight 30 Laser System (NS3000) recalled by New Star Lasers	New Star Lasers	Other	8 states

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