ReNew — Class II medical device recall Z-2916-2016
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-2916-2016 |
|---|---|
| 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 | 5 systems |
| Reason classes | labeling |
| Serial numbers | ABKK03, ABKK04, ABKM02, ABSG01, ABUP01 |
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 the great and small saphenous veins associated with varicose veins and varicosities, and; for laser assisted lipolysis
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
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2916-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
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.