{
  "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": [
    {
      "country": "United States",
      "city": "Waltham",
      "address_1": "920 Winter St",
      "reason_for_recall": "Dialysate Port Leak During Priming of the Dialyzers",
      "address_2": "",
      "product_quantity": "3,460,672 units",
      "code_info": "Lot Numbers:  13LU01001  13KU05018  13LU05001  13KU06026  13LU06001  13LU06002  13LU05002  13LU06003  13LU01007  13LU01008  13LU01009  13LU05003  13LU05004  13LU05005  13LU05006  13LU05007  13LU05008  13LU06004  13LU06005  13LU06006  13LU06008  13LU06009  13LU06010  13LU06011  13LU06012  13LU06013  13LU06014  13LU06015  13LU06016  13LU01010  13LU01011  13LU06017  13LU06018  13LU01012  13LU01013  13LU05014  13LU06019  13LU06020  13LU06021  13LU01015  13LU05015  13LU06022  13NU05002  13NU06002  13NU01004  13NU05003  13NU06003  13NU06004  13NU06007  13NU01005  13NU01006  13NU01007  13NU01008  13NU06008  13NU06009  13NU06010  13NU06011  13NU06012  13NU06013  13NU06014  13NU01009  13NU01010  13NU06015  13NU06016  13NU06017  13NU06018  13NU06020  13NU06021  13NU06022  13NU06023  13NU06024  13NU06025  13NU06026  13NU06027  13NU01015  13NU01016  13NU01017  13NU01018  13PU01001  13PU01002  13PU01003  13NU06029  13PU06001  13PU06002  13PU06018  13PU01013  13PU01014  13PU01015  13PU01017  13PU06019  13PU06020  13PU06021  13PU06022  13PU06023  13PU06024  13PU06025  13PU06026  13PU06027  13PU06028  13SU06004  13SU06005  13LU06023  13LU06024  13LU06025  13LU06027  13LU06028  13NU06001  13LU05016  13LU01016  13LU01017  13NU01001  13LU05017  13NU01002  13PU06003  13PU01004  13PU01007  13PU06006  13PU06007  13PU01008  13PU01010  13PU01011  13PU01012  13PU06015  13PU06016  13PU06017",
      "center_classification_date": "20140226",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and the country of: Mexico.",
      "state": "MA",
      "product_description": "Optiflux F160NRe High Flux Dialyzers; Product Number: 0500316E.    Single Use acute or chronic hemanalysis treatment.",
      "report_date": "20140305",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "recall_number": "Z-1098-2014",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "67313",
      "termination_date": "20210518",
      "more_code_info": "",
      "recall_initiation_date": "20140204",
      "postal_code": "02451-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}