{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Franklin",
      "address_1": "2165 Earlywood Dr",
      "reason_for_recall": "The text on the patient pack is correct and the product itself remains unchanged. FlexMedics does not expect device failures; Instead, there is an opportunity for misuse of the device if the label is not read. If the band is too small, the treatment may be more aggressive. It is important to note that elastic band force decreases over time. If the band is too small and still applied, the band could break. Both circumstances could result in temporary patient discomfort.",
      "address_2": "",
      "product_quantity": "371 pks of 100 elastics (Domestic 127 pks, Foreign 244 pks)",
      "code_info": "Part Number: AMD36, AMD56, AMH14, AMH18, AMH36, LFH14, LFH36, LFM14, LFM36. Lot Number: 802028, 811671, 811672, 811673, 813660, 813666, 813669, 822724, 827161, 827172, 827173, 830878, 832605, 835151, 835158",
      "center_classification_date": "20210303",
      "distribution_pattern": "Worldwide distribution - US Nationwide distribution in the states of CA, CT, FL, IL, KY, MI, MN, MS, MT, NH, NJ, NY, NC, TN, TX, UT, VT, WA, WV, AR, IL, and the countries of Spain, Netherlands, New Zealand, Germany, France, Czech Republic, Greece, Poland, Thailand, Belgium, Denmark, United Kingdom, Canada.",
      "state": "IN",
      "product_description": "Band, Elastic, Orthodontic - Product Usage: Orthodontic elastics, also referred to as rubber bands, are small stretchy loops of rubber that help move teeth into proper alignment during orthodontic treatment. Their purpose is to create additional force for tooth movement in any of the three dimensions that is more difficult using braces alone.",
      "report_date": "20210310",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "G & H Wire Company",
      "recall_number": "Z-1164-2021",
      "initial_firm_notification": "E-Mail",
      "product_type": "Devices",
      "event_id": "87248",
      "termination_date": "20210920",
      "more_code_info": "",
      "recall_initiation_date": "20210121",
      "postal_code": "46131-8879",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}