{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Grand Rapids",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93237",
      "recalling_firm": "SunMed Holdings, LLC",
      "address_1": "2710 Northridge Dr Nw Ste A",
      "address_2": "N/A",
      "postal_code": "49544-9112",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution including in the states of AR,  AZ, CA¿CO, CT, FL, GA, IA, IL, IN,  KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.",
      "recall_number": "Z-0368-2024",
      "product_description": "Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include:     1.\tCuraplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD;     2.\tCuraplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH;     3.\tCuraplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN;     4.\tCuraplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN;     5.\tCuraplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.",
      "product_quantity": "N/A",
      "reason_for_recall": "A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.",
      "recall_initiation_date": "20231011",
      "center_classification_date": "20231121",
      "report_date": "20231129",
      "code_info": "UDI-DI:  00810071633126, Item # 2442-BVMCIN;  UDI-DI:  00812277037050, Item # 2442-BVMPAD;  UDI-DI:  00812277037074, Item # 2442-BVMPCH;  UDI-DI:  00812277037081, Item # 2442-BVMPIN;  UDI-DI:  00812277037067, Item # 2442-BVMPSA.  All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.",
      "more_code_info": ""
    }
  ]
}