{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Carlsbad",
      "address_1": "2885 Loker Ave E",
      "reason_for_recall": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile.",
      "address_2": "",
      "product_quantity": "",
      "code_info": "D163434",
      "center_classification_date": "20170501",
      "distribution_pattern": "US Nationwide Distribution",
      "state": "CA",
      "product_description": "Dressing Knee/Shldr, P/N 02328    Product Usage:  These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.",
      "report_date": "20170510",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Breg Inc",
      "recall_number": "Z-1901-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "76994",
      "termination_date": "20170623",
      "more_code_info": "",
      "recall_initiation_date": "20170330",
      "postal_code": "92010-6626",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}