{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Romulus",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "63583",
      "recalling_firm": "Metrex Research, LLC.",
      "address_1": "28210 Wick Rd",
      "address_2": "N/A",
      "postal_code": "48174-2639",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and countries of: Australia, Canada, and Europe.",
      "recall_number": "Z-0444-2013",
      "product_description": "Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier  The intended use of these devices is to protect both patient and healthcare worker from transfer of microorganisms, body fluids and particulate matter.",
      "product_quantity": "3,348 units",
      "reason_for_recall": "The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve 4511, which fits 11mm light guides, actually contain Pinnacle Cure Sleeves that fit 7mm or 8mm light guides (part number 4500).",
      "recall_initiation_date": "20110920",
      "center_classification_date": "20121127",
      "termination_date": "20121129",
      "report_date": "20121205",
      "code_info": "Part Number  Lot Number     4511                       201008270110"
    }
  ]
}