New Star Lasers Recalls ReNew Dermatology Devices for Labeling Errors
New Star Lasers is recalling five ReNew 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, but the source text explicitly states no illnesses or injuries were reported, and the hazard is limited to a labeling notification failure rather than a direct physical defect or contamination.
Plain-English summary
New Star Lasers, Inc. is recalling five ReNew (a.k.a. Trio) laser systems used for dermatology procedures, including incision, excision, and treatment of fine lines and wrinkles. 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 devices are distributed in the United States only. The specific serial numbers for the recalled units are ABKK03, ABKK04, ABKM02, ABSG01, and ABUP01. The source text does not report any illnesses, injuries, or deaths associated with this recall.
Consumers who possess these specific serial numbers should contact New Star Lasers, Inc. for instructions on how to proceed with the recall.
The recalled product
- Product
- ReNew (a.k.a. Trio) Dermatology: for use in dermatology for incision, excision, ablation and vaporization with hemostasis of soft tissue; for use in the treatment of fine lines and wrinkles; for treatment of back acne and atrophic acne scars; for treatment of reflux of…
- Manufacturer
- New Star Lasers, Inc.
- Category
- Medical Device — Laser Systems
- Hazard
- Affected units
- 5
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers: ABKK03 ABKK04 ABKM02 ABSG01 ABUP01.
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.
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