Cutera brand truSculpt infrared System — Class II medical device recall Z-0427-2014
Terminated recall by Cutera, Inc., reported 2013-12-18, distributed nationwide. Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck
| Recall number | Z-0427-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cutera, Inc., Brisbane, CA, United States |
| Recall initiated | 2013-10-16 |
| Classified | 2013-12-09 |
| Reported by FDA | 2013-12-18 |
| Terminated | 2013-12-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 451 |
| Serial numbers | TS10002, TS10008, TS10014, TS10015, TS10017, TS10018, TS10022, TS10023, TS10024, TS10025, TS10029, TS10032, TS10033, TS10035, TS10037, TS10039, TS10040, TS10045, TS10046, TS10048, TS10049, TS10050, TS10052, TS10054, TS10055 and 59 more |
Product
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Reason for recall
Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.
Machine access
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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.