{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Carson City",
      "state": "NV",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97704",
      "recalling_firm": "DSAART LLC",
      "address_1": "2950 Arrowhead Dr",
      "address_2": "",
      "postal_code": "89706-0488",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "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  O.U.S.: N/A",
      "recall_number": "Z-0945-2026",
      "product_description": "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",
      "product_quantity": "118 implants",
      "reason_for_recall": "Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.",
      "recall_initiation_date": "20250926",
      "center_classification_date": "20251218",
      "report_date": "20251224",
      "code_info": "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 Number: 501-307 UDI-DI code: B490501307 Lot Numbers: 24-09-010 24-12-002 25-04-007  Model/Catalog Number: 501-309 UDI-DI code: B490501309 Lot Number: 24-02-022  Model/Catalog Number: 501-310 UDI-DI code: B490501310 Lot Numbers: 24-10-010 25-02-009",
      "more_code_info": ""
    }
  ]
}