{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Waukesha",
      "state": "WI",
      "country": "United States",
      "classification": "Class III",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "82937",
      "recalling_firm": "GE Healthcare, LLC",
      "address_1": "3000 N Grandview Blvd",
      "address_2": "N/A",
      "postal_code": "53188-1615",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (nationwide)  including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malta, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Palestine (state of), Panama, Poland, Qatar, Republic of Serbia, Romania, Russia, Saudia Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Tajikistan, Tanzania, Thailand, Trinidad and Tobago, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.",
      "recall_number": "Z-1876-2019",
      "product_description": "ECG leadwire sets:   REF/Catalog Number\tDescription  2106389-001\tECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in  2106389-002\tECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in  2106389-003\tECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in  2106389-004\tECG Leadwire set, 5-lead, grouped, grabber, IEC, 130 cm/ 51 in  2106389-005\tECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in  2106389-006\tECG Leadwire set, 5-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in  2106390-001\tECG Leadwire set, 3-lead, grabber, AHA, 74 cm/ 29 in  2106390-002\tECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51 in  2106390-003\tECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29 in  2106390-004\tECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51 in  2106391-001\tECG Leadwire set, 5-lead, grabber, AHA, 74 cm/ 29 in  2106391-002\tECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51 in  2106391-003\tECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29 in  2106391-004\tECG Leadwire set, 5-lead, grabber, IEC, 130 cm/ 51 in  2106391-005\tECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in  2106391-006\tECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in  2106393-001\tECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 cm/ 51 in  2106393-002\tECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 cm/ 51 in  2106393-003\tECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 in  2106393-004\tECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm/ 29 in  2106397-001\tECG Leadwire set, 6-lead, grouped, grabber, AHA, 74 cm/ 29 in  2106397-002\tECG Leadwire set, 6-lead, grouped, grabber, AHA, 130 cm/ 51 in  2106397-003\tECG Leadwire set, 6-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in  2106398-001\tECG Leadwire set, 6-lead, grouped, grabber, IEC, 74 cm/ 29 in  2106398-002\tECG Leadwire set, 6-lead, grouped, grabber, IEC, 130 cm/ 51 in     The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.",
      "product_quantity": "58,045 units (31,108 US; 26937 OUS) in total",
      "reason_for_recall": "ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.",
      "recall_initiation_date": "20190510",
      "center_classification_date": "20190625",
      "termination_date": "20240524",
      "report_date": "20190703",
      "code_info": "product does not have lot or serial codes    REF/Catalog Number GTIN/UDI  2106389-001 00840682139960  2106389-002 00840682139779  2106389-003 none   2106389-004 none  2106389-005 00840682139786  2106389-006 none  2106390-001 00840682139687  2106390-002 00840682140232  2106390-003 none  2106390-004 none  2106391-001 00840682140799  2106391-002 00840682139830  2106391-003 none  2106391-004 none  2106391-005 00840682140348  2106391-006 none   2106393-001 00840682140287  2106393-002 none  2106393-003 00840682139885  2106393-004 none  2106397-001 00840682140522  2106397-002 00840682140461  2106397-003 00840682140041  2106398-001 none  2106398-002 none"
    }
  ]
}