{
  "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": "Burlington",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78704",
      "recalling_firm": "Cosman Medical, LLC",
      "address_1": "22 Terry Ave",
      "address_2": "N/A",
      "postal_code": "01803-2516",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and country of Canada.",
      "recall_number": "Z-0687-2018",
      "product_description": "Nitinol TC Reusable Electrodes (TCN), Model Numbers: 1)TCN-10, 2) TCNK-10-R*, 3)TCN-10-3M, 4) TCNK-15, 5) TCN-15, 6) TCNK-15-C, 7) TCN-15-3M, 8) TCNK-15-R*, 9) TCN-20, 10) TCNK-20, 11) TCN-20-3M*, 12) TCNK-20-C*, 13) TCN-5, 14) TCNK-20-R*, 15) TCN-5-3M, 16) TCNK-5, 17) TCNK-10, 18) TCNK-5-C, 19) TCNK-10-C & 20) TCNK-5-R*.     The TCN devices are indicated for use in radiofrequency (RF) heat lesioning of peripheral nerve tissue only.",
      "product_quantity": "11250 units (10,460 USA; 790 OUS)",
      "reason_for_recall": "After multiple reprocessing cycles, the epoxy resin which holds the TCN Electrode in the hub can exhibit signs of damage. In some cases, this damage may result in the inability to fully remove blood and/or tissue residuals prior to cleaning and re-sterilizing the device.",
      "recall_initiation_date": "20170705",
      "center_classification_date": "20180222",
      "termination_date": "20180914",
      "report_date": "20180228",
      "code_info": "All TCN electrodes with model numbers below.    Cat # TCN-10  Lot #  4717  4745  4851  4852  4916  5061  5193  5196  5372  5375  6111  6112  6627  6740  6746  6747  6819  6925  7525  7526  7806  8294  8422  8583  8942  9148  9327  9373  9374  9574  9978  A041  A143  A415  A435  A785  A797  B060  B061  B202  B264  B437  B814  B815  B901  B902  B903  C526  C527  C834  C846  D025  D157  D158  D238  D239  D602  D656  D685  D686  D946  D947  E129  E360  E382  E409  E410  E583  E714  E718  E886  E974  F074  F086  F101  F104  F112  F113  F178  F227  F228  F365  F366  F367  F368  F427  F428  F429  F555  F708  F709  F710  F711  F790  F791  F887  F888  F889  G007  G008  G116  G118  G119  G120  G152  G170  G171  G172  G352  G963  H011  H012  H016  H088  H089  H284  H347  H487  H488  H507  H595  H850  H872  H932  I011  I012  I056  I057  I145  I146  I236  I237  I246  I247  I294  I400  I401  I402  I448  I449  I450  I451  I547  I548  I580  I616  I617  I841  I842  I918  I919  I959  J008  J102  J180  J181  J306  J307  J308  J560  J561  J680  J808  J810  J811  J958  J959  K165  Cat # TCN-10-3M  Lot #  B463  B612  C711  D430  D781  E414  E508  E618  E972  F426  F523  F604  F788  G075  G383  G413  G611  G761  G764  G826  G968  H085  H093  H286  H324  H345  H496  H582  H614  H735  I013  I578  I619  I751  J511  J515  J563  J682  J730  Cat # TCN-15  Lot #  4746  4854  4901  4917  5060  5194  5197  5373  5376  5557  6741  6820  7227  8295  8943  9165  9386  9575  A078  A416  A434  B062  B438  B904  C060  C212  C285  C845  D240  D241  D603  D950  E133  E381  E411  E584  E715  E970  F072  F183  F229  F369  F396  F430  F431  F712  F713  F789  F890  F891  G000  G169  G440  G943  G952  H004  H090  H285  H508  H594  H608  I399  I409  I452  I453  I549  I579  I615  I843  I920  I960  J101  J182  J310  J562  J681  J812  J813  J960  J961  Cat # TCN-15-3M  Lot #  B613  C707  E509  F714  G168  H094  H287  H325  H346  I752  J564  Cat # TCN-20  Lot #  H091  J183  5077  5199  5558  6821  6832  6924  8944  9576  Cat # TCN-5  Lot #  A417  A786  B439  C528  D242  D687  D945  E130  E625  E887  F076  F201  F230  G266  G762  H015  H092  H619  I144  I618  J100  J184  J309  J731  4747  4853  4918  5062  5195  5198  5374  5377  6748  6822  7640  8945  9577  Cat # TCN-5-3M  Lot #  B614  D024  F946  G076  H095  J886"
    }
  ]
}