{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "San Clemente",
      "state": "CA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "86816",
      "recalling_firm": "ICU Medical, Inc.",
      "address_1": "951 Calle Amanecer",
      "address_2": "N/A",
      "postal_code": "92673-6212",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "U.S. Nationwide distribution including in the states of AL, AR, CA, CO, FL, IL, KY, MD, ME, MI, NC, NJ, OH, PA, TN, TX, VT, WA and WI. O.U.S.: None",
      "recall_number": "Z-0859-2021",
      "product_description": "icumedical Cogent\" Hemodynamic Monitoring System - Product Usage: intended for patients for whom the monitoring of continuous cardiac output and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician.",
      "product_quantity": "220 units",
      "reason_for_recall": "Due to a potential software issue, the display may show the incorrect continuous cardiac output (CCO) values after PulseCO calibration.",
      "recall_initiation_date": "20201109",
      "center_classification_date": "20210114",
      "termination_date": "20230419",
      "report_date": "20210120",
      "code_info": "List Number/Item Code: 58400-000  User Interface Module item:  58403-000  Serial Number:  TSI701114  TSI701129  TSI701136  TSI701180  TSI701179  TSH901670  TSH200797  TSH901640  TSH900431  TSI701174  TSH200801  TSH200767  TSI701173  TSI802195  TSH101376  TSH200764  TSH901982  TSH901985  TSH901602  THS901630  TSH901576  TSH901639  TSH901622  TSH901641  TSH901620  TSH901604  TSH901988  TSH901595  TSH901597  TSH901588  TSI701113  TSI701112  TSI701110  TSI701115  TSI701105  TSH900444  TSH900449  TSH901612  TSH901610  TSI701177  TSI701178  TSI701125  TSI701127  TSI701184  TSI701185  TSI701186  TSI701169  TSI701128  TSFA01684  TSFA01695  TSH101367  TSH901666  TSI701119  TSI701120  TSH901642  TSH901674  TSH901662  TSH901626  TSH901644  TSH901627  TSH901572  TSFA01683  TSH101379  TSH901643  TSH200798  TSH900438  TSH900411  TSH901594  TSH901991  TSH200832  TSH901648  TSH101337  TSH200780  TSH200763  TSH900406  TSH900409  TSH200802  TSH900434  TSH901581  TSH901636  TSH901632  TSH901619  TSH901647  TSH900446  TSH101358  TSH901615  TSH900417  TSH900442  TSH900429  TSH901987  TSH901609  TSH901590  TSH901638  TSI701106  TSI701107  TSI701100  TSI701121  TSFA01661  TSH101350  TSH200804  TSH200805  TSH101352  TSH101342  TSH101340  TSH101360  TSH900441  TSH901634  THS901589  TSH901573  TSH901603  TSH901657  TSH901575  TSH901655  TSH901608  TSH901984  TSH901599  TSH901579  TSH900423  TSH901664  TSH901617  THS901633  TSH901624  TSH901592  TSH901582  TSH901649  TSH901673  TSH901672  TSH901591  TSH901611  TSH901584  TSH901646  TSH901645  TSH901605  TSH901667  TSH901990  TSH901586  TSH901587  TSH901625  TSH901989  TSH901635  TSH900432  TSH901571  TSH101370  TSH200749  TSH900420  TSH200775  TSH200826  TSH200799  TSH900414  TSH901651  TSH200759  TSH901986  TSH901650  TSH901621  TSH901596  TSH901613  TSH901616  TSH900430  TSI701162  TSI701134  TSFA01681  TSH101383  TSH200820  TSH101364  TSH200765  TSH900433  TSH901631  TSI701138  TSH101365  140371  TSI802258  140123  140137  TSI701144  TSI701170  TSI701143  TSI701171  TSI701133  TSI701172  TSI701175  TSI701166  TSI701145  TSI701164  TSI701153  TSI701147  TSI701146  TSI701148  TSI701154  TSI701152  TSI701149  TSI701150  TSI701151  TSI701131  TSI701132  TSI701160  TSI701157  TSI701176  TSI701165  TSI701155  TSI701156  TSI701159  TSI701158  TSI701141  TSI701190  TSI701124  TSI701122  TSI701123  TSI701161  TSI701187  TSI701168  TSI701167  TSI701137  TSI701130  TSI701139  TSI701140  TSI701126  TSI701183  TSI701182  TSI701163  TSI900323  TSI802215  TSI900324  TSI802208  TSI802207  TSI802261  TSI802262  TSI900348  TSI802225  TSI900312  TSI701181  TSI802226  TSI802213  TSI900310  TSI900378  TSI802251  TSI900335  TSI900377  TSI900367  TSI900369  TSI802169  TSI900353  TSI900365  TSI900347  TSI900366  TSI900364  TSI900338  TSI900361  TSI900293  TSI900326  TSI900294  TSI900327  TSI900325  TSI900292  TSI802229  TSI802172  TSI900339  TSI802228  TSI900328  TSI900349  TSI900321  TSI900319  TSI802247  TSI900330  TSI900320  TSI802248  TSI802246  TSI802240  TSI802200  TSI902201  TSI802241  TSI802242  TSI802199  TSI802176  TSI802175  TSI701117  TSI701116  TSI701118  TSI900309  TSI900381  TSI900379  TSI900308  TSI900309  TSI900307  TSI900304  TSI900305  TSI900306  TSI701104  TSI701089  TSI701091  TSI701090  TSI900322  TSI900376  TSI900362  TSI802174  TSI900363  TSI701075  TSI701074  TSI701076  TSI701103  TSI701102  TSI701101  TSI701097  TSI701096  TSI701094  TSI701064  TSI701063  TSI701062  TSI701072  TSI701073  TSI701071  TSI701069  TSI701068  TSI701084  TSI701070  TSI701083  TSI701085  TSI701080  TSI701081  TSI701058  TSI701056  TSI701079  TSI701077  TSI701061  TSI701067  TSI701088  TSI701078  TSI802186  TSI900318  TSI802220  TSI900382  TSI802221  TSI900375  TSI802254  TSI802253  TSI802206  TSI802205  TSI802204  TSI900331  TSI802211  TSI802252  TSI900356  TSI802210  TSI802212  TSI900373  TSI701086  TSI802219  TSI900693  TSI701087  TSI900332  TSI802187  TSI900316  TSI900317  TSI900384  TSI802188  TSI802235  TSI802234  TSI900355  TSI802233  TSI900345  TSI802203  TSI802202  TSI900371  TSI900372  TSI802194  TSI900370  TSI900300  TSI802232  TSI802231  TSI900359  TSI900360  TSI900298  TSI802223  TSI900358  TSI802189  TSI900299  TSI802190  TSI802191  TSI802193  TSI802222  TSI802224  TSJB01598  TSJ900768  TSI802216  TSI802217  TSI802218  TSI900297  TSI900296  TSI900295  TSI802237  TSI802239  TSI802177  TSI802178  TSI900386  TSI802179  TSI900385  TSI900387  TSI802255  TSI802257  TSI802166  TSI802165  TSI900303  TSI802198  TSI802197  TSI802196  TSI900302  TSI900301  TSI802167    List Number/Item Code: 58400-000R  User Interface Module item:  58403-000  Serial Number:  TSH900425  TSFA01656  TSFA01696  TSH101361  TSH900451  TSH901618  TSI701111  TSH901574  TSFA01686  TSH101341  TSH101349  TSH200742  TSH200821  TSH200810  TSH900419  TSH200783  TSH900408  TSH200786  TSFA01697  TSH200770  TSH101391  TSH200748  TSFA01666  TSH200819  THS101345  TSH900402  TSH900447  TSH200769  TSH101382  TSH200822  TSH101344  TSFA01687  TSFA01677  TSH101338  TSH200758  TSH200744  TSFA01659  TSH101373  TSH200792  TSFA01667  TSH200824  TSH200739  TSH200787  TSI900357  TSH200768  TSFA01665  TSH101354  TSH900405  TSH200812  TSH900404  TSH900439  TSH900403  TSH900445  TSH901665  TSH101377  TSH200785  TSH200779  TSHI701057  TSFA01657  TSH200796  TSH200808  TSH900416  TSH200762  TSH200784  TSH101389  TSH200778  TSH200766  TSH200811  TSH200830  TSH900436  TSH900426  TSH900437  TSH200774  TSH101356  TSH101361  TSI701109  TSH200788  TSI701082  TSH200803  TSH101344  TSH101375  TSH200790  TSH200791  TSH200756  TSH200829  TSH900427  TSH200789  TSH900412  TSH200747  TSH200745  TSH900421  TSH200823  TSH900415  TSH900435  TSH101359  TSH900450  TSH900440  TSH901663"
    }
  ]
}