{
  "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": "Wayne",
      "state": "NJ",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "69101",
      "recalling_firm": "Maquet Cardiovascular, LLC",
      "address_1": "45 Barbour Pond Dr",
      "address_2": "N/A",
      "postal_code": "07470-2094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) and countries of: ARGENTINA, AUSTRIA, BANGLADESH, BELARUS, BRAZIL, BRUNEI, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ECUADOR, GERMANY, FINLAND, FRANCE, GREECE, HONG KONG, INDICA, INDONESIA, ISRAEL, ITALY, JAPAN, MEXICO, MALAYSIA, NETHERLANDS, PANAMA, PERU, PHILIPPINES, POLAND, PORTUGAL, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM AND VIETNAM.",
      "recall_number": "Z-0132-2015",
      "product_description": "Acrobat V Vacuum Off-Pump System  OM-9100S    Acrobat SUV Vacuum Off-Pump System  OM-9000S    Axius Xpose 3 Access Device XP-3000    XPOSE 4 Access Device XP-4000    Acrobat V Vacuum Off-Pump System Each Acrobat V Vacuum Off-Pump system is intended for use during performance of cardiac surgical procedures through a sternotomy incision approach.",
      "product_quantity": "16,532 units (19,270 units international)",
      "reason_for_recall": "An internal finding identified the presence of pinholes/cuts in some of the Tyvek pouches of the vacuum tubing sets included as an accessory to Acrobat V Vacuum Off-Pump System, Acrobat SUV Vacuum Off-Pump System, Axius XPOSE 3 Access Device  and XPOSE 4 Access Device.",
      "recall_initiation_date": "20140813",
      "center_classification_date": "20141024",
      "termination_date": "20160330",
      "report_date": "20141105",
      "code_info": "class I 510 K exempt    Acrobat V Vacuum Off-Pump System  OM-9100S  25081832  25083629  25084722  25086515  25087723  25089063  25089942  25090685  25091907  25092783  25092968  25093960  25095207  25096649  25097068  25097679  25097895  25098213        Acrobat SUV Vacuum Off-Pump System  OM-9000S    25083904  25084006  25084498  25084648  25084928  25085094  25085850  25086057  25086330  25086468  25086786  25086869  25087249  25087330  25087412  25087793  25088394  25088704  25089154  25089224  25089724  25090578  25090748  25090943  25091171  25092128  25092272  25092690  25092813  25093167  25093281  25094024  25094065  25094473  25094712  25094860  25095107  25095600  25095769  25096128  25096305  25096404  25096913  25097097  25097336  25097417  25097747  25097801  25098540  25098968      Axius Xpose 3 Access Device XP-3000  25063171  25063264  25064005  25064805  25065216  25066072  25066261  25067242  25067493  25067915  25068869  25070671  25071619  25072468  25073684  25075060  25077055  25077999  25078510  25078808  25080773  25081495  25082997  25084179  25086061  25087498  25088896  25090502  25090832  25091779  25092248  25092884  25093619  25094030  25095768  25096118  25096687  25097508  25098402  25098904        XPOSE 4 Access Device XP-4000    25063351  25063594  25064160  25064428  25064917  25065315  25065547  25067036  25067396  25068245  25068555  25069189  25069589  25069971  25070492  25070808  25071242  25072056  25072852  25073562  25074441  25075249  25075644  25076681  25077208  25077638  25078154  25079334  25079975  25080256  25080465  25081324  25081566  25081959  25083287  25083699  25084533  25085038  25085516  25085696  25086333  25086530  25087192  25088336  25088517  25089557  25089623  25090324  25090692  25091410  25091811  25092398  25092567  25093083  25093570  25094620  25094845  25095211  25095862  25097087  25097274",
      "more_code_info": ""
    }
  ]
}