# FDA recall Z-0947-2026

> **DSAART LLC** · Class II · device recall initiated 2025-09-26.

## 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.

## Distribution

U.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY, OH, OK, PA, PR, TX, UT, VA, WA, and WI  O.U.S.: N/A

## Key facts

- **Recall number:** Z-0947-2026
- **Recalling firm:** DSAART LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-26
- **Report date:** 2025-12-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carson City, NV, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0947-2026

## Citation

> AI Analytics. FDA recall Z-0947-2026. Retrieved 2026-09-27 from https://api.ai-analytics.org/recall/Z-0947-2026. Source: US FDA. Licensed CC0.

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