{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "McHenry",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "80078",
      "recalling_firm": "Medela Inc",
      "address_1": "1101 Corporate Dr",
      "address_2": "N/A",
      "postal_code": "60050-7006",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution domestically to AR, CA, FL, GA, IL, IN, LA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TX.      Distributed internationally to Spain, Italy, Denmark, Sweden, Switzerland, Netherlands.",
      "recall_number": "Z-2528-2018",
      "product_description": "Invia Motion Negative Pressure Wound Therapy System.  Labeled as:      a. Endure Negative Pressure Wound Therapy (Model 087.4010);    b. 15 Days Negative Pressure Wound Therapy (Model 087.4012);    c. 60 Days Negative Pressure Wound Therapy (Model 087.4014);    d. Endure Negative Pressure Wound Therapy (Model 087.4020 );    e. 15 Days Negative Pressure Wound Therapy (Model 087.4022);    f. 60 Days Negative Pressure Wound Therapy (Model 087.4024).      Product Usage:  The Invia Motion Negative Pressure Wound Therapy (NPWT) system is indicated for patients who would benefit from a suction device (NPWT) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.",
      "product_quantity": "778 units",
      "reason_for_recall": "Device may display a battery missing error.",
      "recall_initiation_date": "20180207",
      "center_classification_date": "20180723",
      "termination_date": "20181204",
      "report_date": "20180801",
      "code_info": "a. Endure Negative Pressure Wound Therapy (Expected life 3 years);    b. 15 Days Negative Pressure Wound Therapy (Expected life 15 days);    c. 60 Days Negative Pressure Wound Therapy (Expected life 60 days);    d. Endure Negative Pressure Wound Therapy (Expected life 3 years);    e. 15 Days Negative Pressure Wound Therapy (Expected life 15 days);    f. 60 Days Negative Pressure Wound Therapy (Expected life 60 days).      Serial No. 1670458   1670488; 1670490; 1670492; 1670496   1670512; 1675368   1675419; 1675421   1675431; 1675433   1675443; 1675449; 1676316   1676365; 1676662   1676709; 1676711; 1676713; 1676715; 1676718 - 1676753; 1676755   1676756; 1676758   1676759; 1676762   1676861; 1677718   1677767; 1679752   1679765; 1679767   1679851; 1689658   1689757; 1696087   1696088; 1696095   1696111; 1696113   1696136; 1696356   1696455; 1697916   1697965; 160884   885; 1660887; 1660894   895; 1660901   903; 1660907; 1660915; 1660918   919; 1660921   22; 1660929; 1660934   935; 1660937; 1660940; 1660953; 1660955; 1660957   959; 1660961   963; 1660966; 1660969; 1660977   980; 1660986; 1660988; 1660991   998; 16611001   002; 1661005; 1661013   014; 1661018; 1661020; 1661032; 1661042; 1661052; 1661055; 1661062; 1661064; 1661066; 1661069; 1661076; 1661078; 1661081; 1661083; 1661086; 1661090; 1661092; 1661094   096; 1661099   112; 1661115; 1661117; 1661122; 1661123; 1662223; 1662230; 1662233; 1662237; 1662241   243; 1662245; 1662247   248; 1662252; 1662255   260; 1662263; 1662265   266; 1668362   369; 1668380   385; 1668392   394; 1668396   398; 1668402   403; 1668426; 1668430; 1668437; 1668441; 1668447; 1668451   452; 1668454   455; 1668458; 1668463; 1668466; 1668469; 1668473; 1668488; 1668494   495; 1668506   507; 1668512   515; 1668520   529; 1669591   593; 1669595   601; 1670635; 1670638; 1670641   642; 1670683   689; 1670694; 1670696; 1670698   706; 1670997; 1660883   884; 1660886; 1660888   893; 1660895   900; 1660904   906; 1660908   914; 1660916   917; 1660920; 1660923   933; 1660936   952; 1660954; 1660956; 1660960; 1660964   965; 1660967; 1660974   976; 1660981   984; 1660986   987; 1661000; 1661010; 1661021; 1661029; 1661036; 1661040; 1661049; 1661056; 1661060; 1661065; 1661073; 1661080; 1661084   085; 1661087; 1661089; 1661091; 1661093; 1661095; 1661097   098; 1661100   116; 1661118   121; 1661123   124; 1662225; 1662227; 1662232; 1662234; 1662236; 1662238   240; 1662244; 1662249   250; 1662253   254; 1662261   262; 1662264; 1668350; 1668375   376; 1668379; 1668386   387; 1668389   391; 1668395; 1668399   401; 1668405; 1668407   408; 1668410   416; 1668418   419; 1668421   425; 1668427; 1668432   439; 1668443   445; 1668447; 1668449; 1668453; 1668456   457; 1668459   462; 1668467   468; 1668471; 1668474; 1668481; 1668484; 1668492   494; 1668496   497; 1668501   502; 1668509   510; 1668514; 1668516   517; 1668520; 1668522;"
    }
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}