FDA Device recall Z-0945-2026
Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code:…
- FDA Device
- Class II
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class II recall of Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code:… by Dsaart, citing due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0945-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-26 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Dsaart |
| Distribution | 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 |
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
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
Identifiers
| code_info | Gluteal Implant Model/Catalog Number: 501-101 UDI-DI code: B490501101 Lot Number: 24-01-030 Model/Catalog Number: 501-…Gluteal Implant Model/Catalog Number: 501-101 UDI-DI code: B490501101 Lot Number: 24-01-030 Model/Catalog Number: 501-103 UDI-DI code: B490501103 Lot Numbers: 24-12-003 25-06-014 25-07-022 Model/Catalog Number: 501-105 UDI-DI code: B490501105 Lot Numbers: 24-07-012 24-09-013 Model/Catalog Number: 501-206 UDI-DI code: B490501206 Lot Number: 24-06-017 Model/Catalog Number: 501-301 UDI-DI code: B490501301 Lot Numbers: 23-10-020 25-01-021 Model/Catalog Number: 501-302 UDI-DI code: B490501302 Lot Numbers: 24-12-001 25-01-016 25-03-003 Model/Catalog Number: 501-303 UDI-DI code: B490501303 Lot Numbers: 24-10-004 24-11-001 25-01-017 25-02-011 25-03-003 25-04-009 Model/Catalog Number: 501-304 UDI-DI code: B490501304 Lot Numbers: 24-01-005 24-10-005 24-02-018 24-12-016 Model/Catalog Number: 501-305 UDI-DI code: B490501305 Lot Numbers: 24-09-009 25-01-001 25-03-004 25-04-010 Model/Catalog Number: 501-306 UDI-DI code: B490501306 Lot Numbers: 24-10-011 25-01-002 25-06-027 Model/Catalog Nu |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0945-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.