Class II — Accure Acne, Inc
| Recalling firm | Accure Acne, Inc. |
|---|---|
| Registered facility | ACCURE ACNE, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher-than-expected laser energy to epidermal tissue, which may cause blistering. |
| Product | Accure Laser System, Model: PFMS00004 |
| Quantity | 22 |
| Distribution | US distribution to states of: CO, CA, CT, NY, NJ, MN, LA, OH, MA, TX |
| Initiated | 2023-12-06 |
| Classified | 2024-01-20 |
| Recall number | Z-0778-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Accure Acne, Inc (Z-0778-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93696/
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