Brand Name: AART Malar Implant Product Name: Malar Implant… — Class II medical device recall Z-0947-2026
Ongoing recall by DSAART LLC, reported 2025-12-24, distributed in AR, AZ, CA, CO, CT, DC, FL, GA…. Due to manufactured products that deviated from established specifications and being distributed without obtai
| Recall number | Z-0947-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DSAART LLC, Carson City, NV, United States |
| Recall initiated | 2025-09-26 |
| Classified | 2025-12-18 |
| Reported by FDA | 2025-12-24 |
| Distributed | AR, AZ, CA, CO, CT, DC, FL, GA, IL, KY, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, WI |
| Quantity | 2 implants |
| Lot numbers | 24-01-014, 24-01-015 |
| Model numbers | 401-202-5, 401-202-6 |
Product
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B4904012025 401-202-6 Malar Implant style 2 size 2 right UDI-DI code: B4904012026
Reason for recall
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
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-0947-2026. 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.