{
  "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": [
    {
      "country": "United States",
      "city": "Minneapolis",
      "address_1": "710 Medtronic Pkwy",
      "reason_for_recall": "Medtronic is initiating a voluntary product recall for specific lot numbers of the Affinity Fusion¿ Oxygenators with Balance¿1 Biosurface. These are distributed as stand-alone devices, or as a combination unit with the Affinity Fusion Cardiotomy/Venous Reservoir, or as part of tubing packs. Medtronic has identified an out-\u0013of-specification condition exhibiting additional plastic (flash) in the arterial sampling port adjacent to the arterial outlet port of the oxygenator.",
      "address_2": "NE Mailstop LS245",
      "product_quantity": "5609 (663 US; 4946 OUS)",
      "code_info": "Product UPN/GTIN Lot Number Product Number  00643169650749 212028376 HY8N22R8  00643169802421 211984809 BB9D23R3  00643169707801 211991294 BB1D41R27  00643169871908 212073806 HY8B75R12  00643169621473 211950617 BB8U95R1  00643169860322 211865249 BB8E47R15  00643169865365 211975385 BB9D32R2  00643169860322 211991184 BB8E47R15  00643169717336 211991250 BB8Q09R2  00643169792852 211991385 BB9G59R5  00643169740020 211991295 HY8C67R10  00643169649101 211991248 BB7H73R14  00643169868120 212028234 BB8G43R3  00643169860322 212028305 BB8E47R15  00643169873032 212034498 HY9L88R2  00643169534629 212109150 BB7Z44R6  00643169591738 211846477 BB1A19R44  00643169786790 211991196 BB8X02R7  00643169639058 211846421 BB8N94R4  00643169649767 211991286 HY8J73R6  00643169869783 211991482 BB9E16R4  00643169861534 211914227 SSHY9M26R  00643169869516 211974259 BB9L66R  00643169872127 212020797 BB9L72R1  00643169736283 212028295 BB8S37R11  00643169776807 212028317 BB7X32R12  00643169546431 212028362 BB8C09R4  00643169786042 212028304 BB8Y15R1  00643169471597 212028389 BB4W65R13  00643169793699 212073805 BB8C33R6  00643169792036 211846376 BB8N34R5  00643169631649 212021402 BB8T05R1  00643169587106 212073934 HY0W84R28  00643169862920 211991252 HY8H59R17  00643169845121 212073924 BB4B15R13  00643169648111 211885327 BB8A57R11  00643169741720 211804528 BB3M00R29  00643169700284 211807907 HY1F66R18  00643169766839 211957793 BB8D44R4  00643169518131 211957865 HY8B26R4  00643169463929 211885289 BB5Z97R14  00643169714229 211991298 BB7U21R17  00643169617971 211918715 BB4Z62R17  00643169648111 211991256 BB8A57R11  00643169463929 211991381 BB5Z97R14  00643169724457 211892942 BB9B43R2  00643169862036 211951238 BB9H96R  00643169552852 211991198 BB8L58R3  00643169430143 212028385 BB1S56R19  00643169467873 211957783 BB7J04R9  00643169860322 212028306 BB8E47R15  00643169711945 212028358 BB8T77R2  00643169661295 212028419 HY8M65R2  00643169869820 212046220 HY7G33R8  00643169842441 212073804 HY8R55R3  00643169839274 212073871 HY5V41R19  00643169652941 212073987 BB8D56R9  00643169572263 212074010 HY8L55R5  00643169645424 212074022 BB8M16R3  00643169583238 211991253 CB2V10R24  00643169876903 212100880 BB8U52R8  00643169354869 13182438 BB841  00643169354883 13182603 BB841  00643169354883 13182626 BB841  00643169354869 13182721 BB841  00643169354869 13182733 BB841  00643169354883 13182822 BB841  00643169354883 13182950 BB841  00643169354883 13182977 BB841  00643169354883 13182978 BB841  00643169354883 13182979 BB841  00643169354883 13183344 BB841  00643169354869 13183378 BB841  00643169178168 13183475 BB811  00643169855465 211985748 HY9D36R1  00643169506169 211991194 BB5347R11  00643169654815 211991284 HY7W91R13  00643169872134 212020413 HY9B79R6  00643169855465 212028288 HY9D36R1  00643169649767 211991287 HY8J73R6  00643169747852 212028463 BB8A70R7  00643169672093 212028315 BB8X22R  00643169731165 212074008 BB8P98R2  00643169842823 212073900 HY5U30R10  00643169692145 212073983 HY7X48R10  00643169354883 13183553 BB841  00643169354883 13183609 BB841  00643169354883 13183727 BB841  00643169354869 13183944 BB841  00643169354883 13183963 BB841  00643169354883 13184174 BB841  00643169354883 13184206 BB841  00643169354883 13184587 BB841  00643169354883 13184871 BB841  00643169354883 13184872 BB841  00643169354883 13184873 BB841  00643169354883 13184952 BB841  00643169354883 13185297 BB841  00643169354883 13185542 BB841  00643169354883 13185788 BB841  00643169354883 13185992 BB841  00643169354883 13186074 BB841  00643169354883 13186127 BB841  00643169178175 13186543 BB811",
      "center_classification_date": "20161219",
      "distribution_pattern": "Worldwide Distribution-US (nationwide) in states of: AK, AZ, CA, CO, CT, FL, IA, IL, IN, KS, KY, LA, MN, ND, NV, NY, SD, TN, TX, WI, WY and countries of: Canada, Chile, Croatia, Germany, Greece, Hungary, Iran, Italy, Latvia,   Lebanon, Poland, Portugal, Romania, Spain, Tanzania, and United Kingdom.",
      "state": "MN",
      "product_description": "Affinity Fusion\" Oxygenator with Integrated Arterial Filter,  Affinity Fusion cardiotomy/Venous Reservoir,  Perfusion Tubing Packs    The Affinity Fusion Oxygenator with Integrated Arterial Filter with or without the Cardiotomy/Venous Reservoir with Balance¿1 Biosurface is intended for use in an extracorporeal perfusion circuit to oxygenate blood and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.",
      "report_date": "20161228",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Medtronic Inc",
      "recall_number": "Z-0826-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75795",
      "termination_date": "20170801",
      "recall_initiation_date": "20161116",
      "postal_code": "55432-5603",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}