# FDA recall Z-0945-2026

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

## Product

Brand Name: AART Gluteal Implant  Product Name: Gluteal Implant  Model/Catalog Numbers:  501-101 - Gluteal Implant style 1 size 1  UDI-DI code: B490501101    501-103 - Gluteal Implant style 1 size 3  UDI-DI code: B490501103    501-101  UDI-DI code: B490501101    501-103 - Gluteal Implant style 1 size 3  UDI-DI code: B490501103    501-105 - Gluteal Implant style 1 size 5  UDI-DI code: B490501105    501-206 - Gluteal Implant style 2 size 6  UDI-DI code: B490501206    501-301 - Gluteal Implant style 3 size 1  UDI-DI code: B490501301    501-302 - Gluteal Implant style 3 size 2  UDI-DI code: B490501302    501-303 - Gluteal Implant style 3 size 3  UDI-DI code: B490501303    501-304 - Gluteal Implant style 3 size 4  UDI-DI code: B490501304    501-305 - Gluteal Implant style 3 size 5  UDI-DI code: B490501305    501-306 - Gluteal Implant style 3 size 6  UDI-DI code: B490501306    501-307 - Gluteal Implant style 3 size 7  UDI-DI code: B490501307    501-309 - Gluteal Implant style 3 size 9  UDI-D

## 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-0945-2026
- **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-0945-2026

## Citation

> AI Analytics. FDA recall Z-0945-2026. Retrieved 2026-09-03 from https://api.ai-analytics.org/recall/Z-0945-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*