{
  "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": "3,744,122",
      "code_info": "Lot Numbers:  13LU02004  13LU02005  13LU02008  13LU03006  13LU03007  13LU03008  13LU04005  13LU04006  13LU04007  13LU04008  13LU04009  13LU04010  13LU03009  13LU03010  13LU03011  13LU03012  13LU04011  13LU04012  13LU03014  13LU02018  13LU03015  13LU03016  13LU03017  13LU03018  13NU03001  13NU02001  13NU03002  13NU03004  13NU03005  13NU02005  13NU02006  13NU02007  13NU03006  13NU03007  13NU03008  13NU03009  13NU05006  13NU05007  13NU05009  13NU03011  13NU03012  13NU04011  13NU05016  13NU05017  13NU05018  13NU03018  13NU04017  13PU02003  13NU03019  13PU03001  13PU03002  13PU03003  13PU05002  13PU05003  13PU02004  13PU02005  13PU02006  13PU02007  13PU03004  13PU03006  13PU03007  13PU03008  13PU05004  13PU02010  13PU02011  13PU02012  13PU03010  13PU04011  13PU04012  13PU04013  13PU05009  13PU05010  13PU05011  13PU02013  13PU02014  13PU02015  13PU02016  13PU02017  13PU03013  13PU03014  13PU03015  13PU03016  13PU03017  13PU04014  13PU05016  13PU05017  13SU05001  13SU02003  13SU03004  13SU02004  13NU04012  13NU05010  13NU05011  13NU02012  13NU02013  13NU02014  13NU03016  13NU03017  13NU04015  13NU04016  13NU05014  13NU05015  13PU04015  13PU04016  13PU04017  13PU04018  13PU05012  13PU05013  13PU05014  13PU05015  13PU02018  13PU02019  13SU02001  13PU04019",
      "center_classification_date": "20140226",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and the country of: Mexico.",
      "state": "MA",
      "product_description": "Optiflux F180NRe High Flux Dialyzers; Product Number: 0500318E.    Single Use acute or chronic hemanalysis treatment.",
      "report_date": "20140305",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Fresenius Medical Care Holdings, Inc.",
      "recall_number": "Z-1100-2014",
      "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"
    }
  ]
}