{
  "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": [
    {
      "country": "United States",
      "city": "Chatsworth",
      "address_1": "19736 Dearborn St",
      "reason_for_recall": "Select lots of SANDEL Weighted Safety Scalpels are packaged with the scalpel blade exposed beyond the safety shield which could compromise the integrity of the package and the sterility of the scalpel leading to injury.",
      "address_2": "",
      "product_quantity": "50 cases (4800 units); 96 cases (576 units)",
      "code_info": "510 K exempt  Device Listing Number D129456  Model Number 2210-N  LN 0563 Jan 2016  LN 2263 Jul 2016",
      "center_classification_date": "20140107",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) including states of:  AL, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MS, NC, NE, NY, OK,  PA, PR, RI, TN, TX and WI; and country of: Canada.",
      "state": "CA",
      "product_description": "Sandel Healthcare Safety Devices Weighted Safety Scalpel #3 Disposable Safety Handle with #10 Blade  Manufactured for: Ansell Sandel Medical Solutions LLC 19736 Dearborn St. Chatsworth, CA 91311 USA  Emergo Europe Molenstraat 15 2513 BH The Hague  The Netherlands   Made in China  Packaged in Mexico  Ansell    A manual surgical scalpel blade for making incisions in various general surgical procedures.",
      "report_date": "20140115",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Ansell Sandel Medical Industries LLC",
      "recall_number": "Z-0635-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67005",
      "termination_date": "20160406",
      "more_code_info": "",
      "recall_initiation_date": "20131112",
      "postal_code": "91311-6509",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}