Accure Laser System — Class II medical device recall Z-0778-2024
Ongoing recall by Accure Acne, Inc, reported 2024-01-31, distributed in CA, CO, CT, LA, MA, MN, NJ, NY…. Laser system's spot tracking system may become misaligned resulting in the possible risk of delivery of higher
| Recall number | Z-0778-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accure Acne, Inc, Boulder, CO, United States |
| Recall initiated | 2023-12-06 |
| Classified | 2024-01-20 |
| Reported by FDA | 2024-01-31 |
| Distributed | CA, CO, CT, LA, MA, MN, NJ, NY, OH, TX |
| Quantity | 22 |
| UPC / GTIN / UDI-DI | 08059173392230 |
| Serial numbers | LAD0000-0001, LAD0000-0003, LAD0000-0004, LAD0000-0005, LAD0000-0006, LAD0000-0008, LAD0000-0009, LAD0000-0010, LAD0000-0011, LAD0000-0012, LAD0000-0013, LAD0000-0014, LAD2075-0623, LAD2076-0623, LAD2216-0623, LAD2232-0723, LAD2356-0723, LAD2357-0723, LAD2507-0723, PROT01-0720, PROT06-1120, PROTO07-1120 |
| Model numbers | PFMS00004 |
Product
Accure Laser System, Model: PFMS00004
Reason for recall
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.
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-0778-2024. 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.