{
  "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": "197189",
      "product_res_number": "Z-0766-2023",
      "event_date_initiated": "2022-12-02",
      "event_date_posted": "2022-12-22",
      "recall_status": "Open, Classified",
      "res_event_number": "91177",
      "product_code": "KKO",
      "product_description": "Lamaze Chill Teether, Fluid-Filled Teething Ring, Model No. Y5288L",
      "code_info": "UDI-DI B268Y5288L0\n\nLot Numbers E1920ALP01 and K1920ALP01",
      "firm_fei_number": "1217805",
      "recalling_firm": "Tomy International Inc.",
      "address_1": "45 Shawmut Rd Fl 3 45 Shawmut Rd",
      "address_2": "Fl 3",
      "city": "Canton",
      "state": "MA",
      "postal_code": "02021-1400",
      "additional_info_contact": "Customer Contact\n866-725-4407",
      "reason_for_recall": "Affected lots of the product are being recalled due to potential microbial growth in the fluid inside the device. if a compromised product is used by a child with a weakened immune system, an infection or other illness could occur.",
      "root_cause_description": "Process control",
      "action": "On 12/2/2022, the firm notified customers with Medical Device Recall letters. Customers were instructed to identify any affected product on hand and dispose of all affected products. The firm may provide payment credits to customers for disposed units. Customers should notify downstream accounts if affected lots were distributed to third parties.\n\nCustomers/Retailers were provided with recall posters to post in a conspicuous location for consumers, to ensure that anyone who purchased a product from the affected lots is notified that they should stop using and dispose of the product.\n\nConsumers should immediately stop using affected product and dispose of it in the trash. Do not return the item to the store. Production code can be found directly on the back of the packaging and on the product itself.\n\nFor more information, consumers can contact TOMY International, Inc. by telephone at 1-866-725-\n4407 from 8:00 a.m. and 4:00 p.m. CT Monday through Friday or visit https://recall.tomy.com/chillteether.html (web URL updated 9/8/23).",
      "product_quantity": "approx 55,000 North America",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Australia, Mauritius, Dominican Republic.",
      "openfda": {
        "k_number": [
          "K092025",
          "K092494",
          "K013587",
          "K082824",
          "K965082",
          "K092781",
          "K052513",
          "K002066",
          "K053493",
          "K123855",
          "K981202",
          "K093370",
          "K072082",
          "K014023",
          "K091198",
          "K092910",
          "K090167",
          "K031094",
          "K093266",
          "K052105",
          "K963912",
          "K083512",
          "K902974",
          "K043033",
          "K955069",
          "K052531",
          "K110615"
        ],
        "device_name": "Ring, Teething, Fluid-Filled",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.5550",
        "device_class": "2",
        "registration_number": [
          "3010435282",
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}