{
  "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": 1
    }
  },
  "results": [
    {
      "cfres_id": "197444",
      "product_res_number": "Z-1017-2023",
      "event_date_initiated": "2022-12-05",
      "event_date_posted": "2023-01-26",
      "recall_status": "Completed",
      "res_event_number": "91320",
      "product_code": "PNN",
      "k_numbers": [
        "K220287"
      ],
      "product_description": "Invisalign Express 10 REF 8512\n\nInvisalign System   Comprehensive REF 9000\n\nInvisalign System   Moderate REF 9001",
      "code_info": "Invisalign Express 10\nProduct Code: 8512\nSO/PID: 215086492 / 18752002\n\nInvisalign System - Comprehensive\nProduct Code: 9000\nSO / PID:\n215072477  / 18747673\n213766469 / 17291917\n215237342 / 16525818\n215211007 / 18799320\n215234241 / 15985771\n215275953 / 18824845\n215035759 / 16193974\n215038858 / 18715205\n215349325 / 18799786\n215125907 / 18746963\n215541695 / 16576036\n215451877 / 14994856\n\nInvisalign System - Moderate\nProduct Code: 9001\nSO/PID:\n214866511 / 18672529",
      "firm_fei_number": "3002519584",
      "recalling_firm": "Align Technology Inc",
      "address_1": "2820 Orchard Pkwy",
      "city": "San Jose",
      "state": "CA",
      "postal_code": "95134-2019",
      "additional_info_contact": "Shirley Stacy\n408-425-4796",
      "reason_for_recall": "3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.",
      "root_cause_description": "Software design",
      "action": "On 12/05/2022, the firm initiated telephone calls with customer to inform them of a voluntary recall of selected Invisalign aligners. Starting on 12/09/2022, the firm sent an \"URGENT Medical Device Correction\" email to customers as a follow-up to a telephone call informing them that selected Invisalign aligners may have the potential clinical impact and therefore may result in unnecessary/unprescribed treatment due to software issue with the new Treatment Planning History feature within ClinCheck software.\n\nCustomers are instructed:\n1. Cease/stop using and dispose of the affected Invisalign case(s), including the aligners and packaging, and treatment PDF form-printed or online\n2. Notify patients to discard the impacted aligners, if they have already been provided to them.  The impacted product can be discarded as per the Doctor Instructions for Use or  Patient Use and Care Instructions.\n\nAs an immediate action, Align Technology has disabled the ClinCheck feature capability from the Treatment Plan History.\n\nFor questions - contact CustomerSupport@aligntech.com or 888-822-5446.",
      "product_quantity": "14 cases (637 aligner and temples)",
      "distribution_pattern": "U.S. Nationwide distribution in the states of  AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.",
      "openfda": {
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          "K192701",
          "K250198",
          "K241153",
          "K152086",
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          "K212828",
          "K252507",
          "K213916",
          "K163677",
          "K200772",
          "K253343",
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        ],
        "registration_number": [
          "3017155477",
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          "3017545364",
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        ],
        "fei_number": [
          "3017155477",
          "3013912897",
          "3016730274",
          "3018126402",
          "3002519584",
          "3004884150",
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          "3000368601",
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          "3003402534",
          "2024258",
          "3027460334",
          "3033714666",
          "3017545364",
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        ],
        "device_name": "Orthodontic Software",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.5470",
        "device_class": "2"
      }
    }
  ]
}