{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 6 } }, "results": [ { "cfres_id": "216371", "product_res_number": "Z-0944-2026", "event_date_initiated": "2025-09-26", "event_date_posted": "2025-12-18", "recall_status": "Open, Classified", "res_event_number": "97704", "product_code": "MIB", "k_numbers": [ "K021820" ], "product_description": "Brand Name: AART Silicone Carving Implant\nProduct Name: Silicone Carving Implant\nModel/Catalog Numbers:\n600-601 - Silicone Carving Implant Style 6 Size 1\nUDI-DI code: B490600601\n\n600-602 - Silicone Carving Implant Style 6 Size 2\nUDI-DI code: B490600602\n\n600-601-9 - Silicone Carving Implant Style 6 Size 1 with Suture Tabs\nUDI-DI code: B4906006019\n\n600-603-9 - Silicone Carving Implant Style 6 Size 3 with Suture Tabs\nUDI-DI code: B4906006039\n\n600-604-9 - Silicone Carving Implant Style 6 Size 4 with Suture Tabs\nUDI-DI code: B4906006049\n\n600-602-3-9 - Silicone Carving Implant Style 6 Size 2 Smooth with Suture Tabs\nUDI-DI code: B49060060239\n\n600-603 -Silicone Carving Implant Style 6 Size 3 \nUDI-DI code: B490600603\n\n600-603-3-9 - Silicone Carving Implant Style 6 Size 3 Smooth with Suture Tabs\nUDI-DI code: B49060060339\n\n600-604 - Silicone Carving Implant Style 6 Size 4\nUDI-DI code: B490600604\n\n600-605 - Silicone Carving Implant Style 6 Size 5\nUDI-DI code: B490600605\n\n600-801 - Silicone Carving Implant Style 8 Size 1\nUDI-DI code: B490600801\n\n600-803 - Silicone Carving Implant Style 8 Size 3\nUDI-DI code: B490600803\n\n600-804 - Silicone Carving Implant Style 8 Size 4\nUDI-DI code: B490600804\n\n\nIntended for Augmentation and reconstructive surgery.\n\n* Pending information", "code_info": "AART Silicone Carving Implant\nModel/Catalog Number: 600-601 - Silicone Carving Implant Style 6 Size 1\nUDI-DI code: B490600601\nLot Numbers:\n25-01-003\n25-01-010\n25-01-022\n25-02-012\n25-03-001\n25-04-004\n25-05-006\n25-05-015\n25-06-011\n25-06-017\n\nModel/Catalog Number: 600-602\nUDI-DI code: B490600602\nLot Numbers:\n25-02-006\n25-02-021\n25-03-007\n25-04-005\n25-05-017\n25-06-015\n\nModel/Catalog Number: 600-601-9\nUDI-DI code: B4906006019\nLot Number:\n25-02-017\n\nModel/Catalog Number: 600-603-9\nUDI-DI code: B4906006039\nLot Number:\n25-02-026\n\nModel/Catalog Number: 600-604-9\nUDI-DI code: B4906006049\nLot Number:\n25-02-018\n\nModel/Catalog Number: 600-602-3-9\nUDI-DI code: B49060060239\nLot Number:\n24-04-011\n\nModel/Catalog Number: 600-603\nUDI-DI code: B490600603\nLot Numbers:\n24-11-005\n25-01-011\n25-02-007\n25-02-020\n\nModel/Catalog Number: 600-603-3-9\nUDI-DI code: B49060060339\nLot Number:\n24-01-013\n\nModel/Catalog Number: 600-604\nUDI-DI code: B490600604\nLot Numbers:\n24-10-013\n25-01-012\n25-02-024\n25-04-012\n\nModel/Catalog Number: 600-605\nUDI-DI code: B490600605\nLot Numbers:\n24-05-003\n25-01-013\n25-06-012\n\nModel/Catalog Number: 600-801\nUDI-DI code: B490600801\nLot Numbers:\n24-11-017\n25-01-004\n25-01-014\n25-01-023\n25-07-009\n\nModel/Catalog Number: 600-803\nUDI-DI code: B490600803\nLot Numbers:\n24-09-016\n25-01-015\n\nModel/Catalog Number: 600-804\nUDI-DI code: B490600804\nLot Number:\n23-10-005", "firm_fei_number": "3003897287", "recalling_firm": "DSAART LLC", "address_1": "2950 Arrowhead Dr", "city": "Carson City", "state": "NV", "postal_code": "89706-0488", "additional_info_contact": "Kurt Holm\n775-8536800", "reason_for_recall": "Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.", "root_cause_description": "No Marketing Application", "action": "On 09/26/2025, the firm emailed a notice to an affected customer informing them that due to identified testing issues, the firm was requesting return of gluteal implants.\n\nOn 11/17/2025, the firm send an \"URGENT Medical Device removal of AART Silicone Implants\" Letter to customer informing them that Alpha Aesthetics is voluntarily removing products as they conduct an analysis to determine the regulatory status of the devices.\n\nCustomers are instructed to:\n1. Either return the affected products that have not been implanted to Alpha Aesthetics at the company's expense, or discard affected products.\n2. Acknowledge their actions via the enclosed \"Medical Device Return Response\" letter/form.\n\nFor questions or further assistance with this removal, contact ** or email **.", "product_quantity": "369 implants", "distribution_pattern": "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\n\nO.U.S.: N/A", "openfda": { "k_number": [ "K022511", "K945552", "K193392", "K042054", "K955368", "K983630", "K974653", "K200073", "K973166", "K982065", "K223051", "K220760", "K955370", "K971613", "K982688", "K042380", "K030808", "K030809", "K974480", "K162624", "K961081", "K971480", "K952732", "K974654", "K021839", "K040042", "K913882", "K973730", "K181387", "K222748", "K960038", "K983041", "K944408", "K171851", "K935571", "K052504", "K241150", "K961057", "K021820", "K954382", "K973728", "K052505", "K974482", "K981851", "K022223" ], "registration_number": [ "3014664527", "3010606546", "3017496797", "1018470", "3003897287", "1061771", "2028924", "2939142", "2029275", "1057421", "2031444" ], "fei_number": [ "1000306431", "3014664527", "1000142697", "3010606546", "3017496797", "1018470", "3003897287", "1000022662", "2939142", "3001890623", "1000511237" ], "device_name": "Elastomer, Silicone Block", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.3620", "device_class": "2" } } ] }