{
  "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": [
    {
      "status": "Terminated",
      "city": "West Chester",
      "state": "OH",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69713",
      "recalling_firm": "Atricure Inc",
      "address_1": "6217 Centre Park Drive",
      "address_2": "N/A",
      "postal_code": "45069",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of:  Canada, ITALY, NETHERLANDS, CZECH REPUBLIC, AUSTRIA, GERMANY, BELGIUM, Hong Kong, SPAIN, UNITED KINGDOM (GREAT BRITAIN), UNITED KINGDOM, JAPAN, FRANCE, FINLAND, LUXEMBOURG, Korea, SWITZERLAND, SWEDEN, Malaysia, ISRAEL, NORWAY, AUSAtralia, COLOMBIA, TURKEY, Thailand, SOUTH KOREA, SAUDI ARABIA, TAIWAN, SOUTH AFRICA, and DENMARK.    The affected product was also distributed to 17 government consignees.",
      "recall_number": "Z-0895-2015",
      "product_description": "Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches    Product Usage:  Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmias. The probe freezes target tissues, creating an inflammatory response (cryo-necrosis) that blocks the electrical conduction pathway.",
      "product_quantity": "19,190 units",
      "reason_for_recall": "Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.",
      "recall_initiation_date": "20141121",
      "center_classification_date": "20141230",
      "termination_date": "20150720",
      "report_date": "20150107",
      "code_info": "The following batch numbers are affected by this recall:  26500  27831  27959  28248  28472  28474  28475  28910  28911  29337  29461  29525  29788  29926  29933  29934  30358  30359  30618  30810  31401  31402  32037  32200  32210  32211  32771  32790  33047  33261  33262  33340  33527  33528  33581  33582  33631  33661  33663  33918  34283  34284  34586  34587  34793  34852  34853  35167  35177  35247  35307  35308  35682  35683  36279  36292  36686  37005  37207  37558  37655  37686  37855  38007  38171  38433  38533  38636  38719  38869  38994  39087  39196  39285  39424  39475  39503  39504  39694  39780  39867  39943  40067  40189  40288  40398  40534  40640  40709  40826  40986  41105  41302  41414  41517  41597  41737  41850  41909  41982  42046  42141  42466  42470  42567  42612  42719  42836  42932  43047  43182  43281  43354  43485  43604  43691  43827  43833  43953  44096  44215  44368  44491  44612  44781  44936  45048  45130  45268  45277  45378  45390  45492  45612  45628  45654  45715  45842  45845  45854  45973  46272  46353  46466  46569  46770  46852  46974  47067  47195  47298  47408  47540  47677  47851  47905  47937  48085  48174  48288  48394  48679  48684  48700  48906  48953  49012  49042  49179  49378  49477  49478  49502  49503  49699  49717  49815  49816  49830  49831  50017  50018  50210  50211  50335  50336  50472  50473  50554  50555  50700  50701  50859  50860  51079  51080  51258  51259  51348  51349  51490  51631  51632  51773  51774  51901  51902  52018  52019  52197  52278  52279  52342  52461  52462  52575  52576  52730  52731  52849  52850  52951  52952  53144  53168  53405  53406  53423  53424  53607  38994A  39087A  39475A  39475AA  39867A  40709A  40709B  42836A  43182A  43182B  43281A"
    }
  ]
}