Brand Name: AART Silicone Carving Implant Product Name: Silicone… — Class II medical device recall Z-0944-2026
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-0944-2026 |
|---|---|
| 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 | 369 implants |
| Lot numbers | 23-10-005, 24-01-013, 24-04-011, 24-05-003, 24-09-016, 24-10-013, 24-11-005, 24-11-017, 25-01-003, 25-01-004, 25-01-010, 25-01-011, 25-01-012, 25-01-013, 25-01-014, 25-01-015, 25-01-022, 25-01-023, 25-02-006, 25-02-007, 25-02-012, 25-02-017, 25-02-018, 25-02-020, 25-02-021, 25-02-024, 25-02-026, 25-03-001, 25-03-007, 25-04-004, 25-04-005, 25-04-012, 25-05-006, 25-05-015, 25-05-017, 25-06-011, 25-06-012, 25-06-015, 25-06-017, 25-07-009 |
| Model numbers | 600-601, 600-601-9, 600-602, 600-602-3-9, 600-603, 600-603-3-9, 600-603-9, 600-604, 600-604-9, 600-605, 600-801, 600-803, 600-804 |
Product
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Size 1 UDI-DI code: B490600601 600-602 - Silicone Carving Implant Style 6 Size 2 UDI-DI code: B490600602 600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs UDI-DI code: B4906006019 600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs UDI-DI code: B4906006039 600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs UDI-DI code: B4906006049 600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs UDI-DI code: B49060060239 600-603 -Silicone Carving Implant Style 6 Size 3 UDI-DI code: B490600603 600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs UDI-DI code: B49060060339 600-604 - Silicone Carving Implant Style 6 Size 4 UDI-DI code: B490600604 600-605 - Silicone Carving Implant Style 6 Size 5 UDI-DI code: B490600605 600-801 - Silicone Carving Implant Style 8 Size 1 UDI-DI code: B490600801 600-803 - Silicone Carving Implant Style 8 Size 3 UDI-DI code: B490600803 600-804 - Silicone Carving Implant Style 8 Size 4 UDI-DI code: B490600804 Intended for Augmentation and reconstructive surgery. * Pending information
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-0944-2026. 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.