New Star Lasers Recalls VariaBreeze Systems Due to Labeling Notification Failure
New Star Lasers is recalling 17 VariaBreeze laser systems because customers were not notified when promotional material was revised to remove outside-use indications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to notify customers of labeling revisions regarding outside-use indications, which is a documentation and labeling issue rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
New Star Lasers, Inc. is recalling 17 VariaBreeze laser systems (Catalog number: 7300-0035-2). These devices are used in podiatry for procedures such as ablation, vaporization, incision, excision, and coagulation of soft tissue, including matrixectomy and wart removal.
The recall was initiated after an FDA inspection found that customers who had received devices with promotional material containing outside-use indications were not notified when the labeling was revised to remove these indications. The affected units are identified by specific serial numbers listed in the recall documentation.
The devices were distributed only within the United States. Customers who possess these devices should contact New Star Lasers, Inc. for further instructions regarding the recall.
The recalled product
- 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…
- Manufacturer
- New Star Lasers, Inc.
- Category
- Medical Device — Laser Systems
- Affected units
- 17
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 recalled by New Star Lasers, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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