Brand Name: AART Gluteal Implant Product Name: Gluteal Implant… — Class II medical device recall Z-0945-2026
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-0945-2026 |
|---|---|
| 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 | 118 implants |
| Lot numbers | 23-10-020, 24-01-005, 24-01-030, 24-02-018, 24-02-022, 24-06-017, 24-07-012, 24-09-009, 24-09-010, 24-09-013, 24-10-004, 24-10-005, 24-10-010, 24-10-011, 24-11-001, 24-12-001, 24-12-002, 24-12-003, 24-12-016, 25-01-001, 25-01-002, 25-01-016, 25-01-017, 25-01-021, 25-02-009, 25-02-011, 25-03-003, 25-03-004, 25-04-007, 25-04-009, 25-04-010, 25-06-014, 25-06-027, 25-07-022 |
| Model numbers | 501-101, 501-103, 501-105, 501-206, 501-301, 501-302, 501-303, 501-304, 501-305, 501-306, 501-307, 501-309, 501-310 |
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-DI code: B490501309 501-310 - Gluteal Implant style 3 size 10 UDI-DI code: B490501310
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-0945-2026. 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.