Data Foundry

Medical device recalls 2016

CT3Plus — Class II medical device recall Z-2914-2016

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 numberZ-2914-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmNew Star Lasers, Inc., Roseville, CA, United States
Recall initiated2016-09-19
Classified2016-09-30
Reported by FDA2016-10-12
Terminated2016-12-13
Reason classeslabeling
Serial numbers3023, 3045, 4002-Z, 4004, 4009, 4014, 4016, 4023, 4030, ABB0271, ABB0388, ABB0423, ABB0862, ABB0900, ABC0363, ABC0921, ABC1067, ABC1193, ABC1252, ABD0501, ABD0757, ABD1363, ABE0101, ABE1258, ABE1663 and 68 more
Model numbers7300-0038, 7300-0038-1

Product

CT3Plus (a.k.a. CT3PZ); Catalog number: 7300-0038/ 7300-0038-1. Dermatology: For use in dermatology for incision, excision, ablation, and vaporization with hemostasis of soft tissue; For treatment of fine lines and wrinkles; For mild to moderate inflammatory acne vulgaris; For back acne and atrophic scarring, and; For podiatry, (incision, excision, and coagulation of soft tissue), including. matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas

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-2914-2016. 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.