{
  "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": "Montvale",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "68586",
      "recalling_firm": "Pentax Medical Company",
      "address_1": "3 Paragon Dr",
      "address_2": "",
      "postal_code": "07645-1782",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution",
      "recall_number": "Z-2116-2014",
      "product_description": "EG-3630U Ultrasound Video Gastroscope  EG-3830UT Ultrasound Video Gastroscope  EG-3870UTK Ultrasound Video Gastroscope  FG-36UX Ultrasound Fiber Gastroscope     Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.",
      "product_quantity": "531 units",
      "reason_for_recall": "Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope.  This may result in patient injury if the Instruction for Use is not followed carefully by the user.",
      "recall_initiation_date": "20140612",
      "center_classification_date": "20140724",
      "termination_date": "20151117",
      "report_date": "20140730",
      "code_info": "Model: EG-3630U    A01013 E010080 E110111 E110159 E110236  A01017 E010082 E110116 E110161 E110237  A01022 E010084 E110118 E110167 E110239  A01025 E010092 E110120 E110169 E110240  A01026 E010093 E110132 E110172 E110256  A01028 E010094 E110134 E110177 E110277  A01029 E010095 E110135 E110179 E110278  A01031 E010096 E110138 E110182 E110282  A01033 E01037 E110139 E110187 E110283  A01036 E01038 E110140 E110188 E110285  E010064 E01039 E110141 E110193 E110287  E010066 E01042 E110144 E110195 E110289  E010069 E01043 E110145 E110202 E110290  E010070 E01046 E110146 E110205 E110306  E010075 E01054 E110147 E110208 E110307  E010077 E01061 E110156 E110210 E110308  E010078 E01062 E110157 E110219    Model: EG-3830UT    E110067 E110160 E110204 E110275 E110374  E110070 E110163 E110206 E110277 E110377  E110074 E110165 E110212 E110286 E110379  E110079 E110168 E110214 E110289 E110426  E110082 E110171 E110224 E110292 E110428  E110093 E110172 E110228 E110295 E110433  E110095 E110174 E110230 E110309 E110439  E110108 E110183 E110243 E110310 E110442  E110126 E110186 E110255 E110323 E110444  E110142 E110189 E110263 E110331 E110454  E110152 E110195 E110265 E110340 E110517  E110153 E110196 E110268 E110341    Model: FG-36UX    A01014 A01049 A01079 A01100 A01166  A01019 A01053 A01080 A01104 A01168  A01020 A01054 A01081 A01105 A01174  A01029 A01055 A01082 A01116 A01183  A01030 A01056 A01084 A01122 A01184  A01033 A01057 A01086 A01126 A01186  A01036 A01068 A01092 A01131 A110260  A01040 A01070 A01096 A01137 A110268  A01046 A01074 A01098 A01142    Model: EG-3870UTK    A110013 A110060 A110095 A110125 A110154  A110021 A110061 A110096 A110126 A110155  A110022 A110062 A110098 A110127 A110156  A110024 A110063 A110099 A110128 A110161  A110025 A110065 A110100 A110129 A110162  A110026 A110067 A110101 A110130 A110163  A110028 A110068 A110104 A110133 A110164  A110029 A110069 A110105 A110134 A110165  A110031 A110070 A110106 A110135 A110166  A110033 A110071 A110107 A110138 A110167  A110038 A110073 A110108 A110139 A110168  A110040 A110076 A110110 A110140 A110169  A110041 A110077 A110111 A110141 A110172  A110042 A110078 A110112 A110142 A110174  A110043 A110080 A110113 A110143 A110175  A110044 A110081 A110114 A110144 A110177  A110045 A110082 A110115 A110145 A110179  A110046 A110084 A110116 A110146 A110180  A110050 A110085 A110117 A110147 A110181  A110051 A110086 A110118 A110148 A110182  A110052 A110087 A110119 A110149 A110183  A110053 A110089 A110121 A110150 A110192  A110054 A110090 A110122 A110151 A110195  A110056 A110092 A110123 A110152 A110196  A110059 A110093 A110124 A110153 A110199  A110203 A110256 A110315 A110379 A110447  A110205 A110257 A110318 A110380 A110448  A110208 A110258 A110320 A110381 A110449  A110210 A110259 A110321 A110383 A110450  A110211 A110261 A110322 A110384 A110451  A110213 A110264 A110323 A110385 A110452  A110214 A110265 A110324 A110387 A110453  A110215 A110266 A110325 A110388 A110454  A110216 A110267 A110326 A110391 A110457  A110217 A110270 A110334 A110393 A110458  A110218 A110271 A110335 A110394 A110459  A110221 A110272 A110336 A110398 A110460  A110222 A110273 A110337 A110401 A110461  A110224 A110276 A110338 A110406 A110462  A110226 A110277 A110339 A110407 A110463  A110227 A110279 A110340 A110410 A110464  A110228 A110280 A110341 A110411 A110465  A110229 A110282 A110342 A110414 A110466  A110230 A110284 A110343 A110416 A110467  A110231 A110285 A110344 A110417 A110470  A110232 A110286 A110345 A110419 A110472  A110233 A110287 A110346 A110420 A110473  A110234 A110288 A110348 A110425 A110475  A110235 A110289 A110350 A110426 A110476  A110236 A110290 A110351 A110427 A110477  A110237 A110291 A110352 A110429 A110479  A110239 A110292 A110353 A110431 A110480  A110240 A110293 A110355 A110433 A110481  A110241 A110294 A110356 A110434 A110482  A110242 A110295 A110357 A110435 A110483  A110243 A110299 A110359 A110438 A110484  A110244 A110300 A110360 A110439 A110485  A110245 A110307 A110361 A110440 A110486  A110248 A110309 A110363 A110441 A110488  A110249 A110310 A110368 A110442 A110492  A110250 A110311 A110372 A110443  A110253 A110313 A110375 A110444  A110255 A110314 A110376 A110445",
      "more_code_info": ""
    }
  ]
}