{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "220053",
      "product_res_number": "Z-2281-2026",
      "event_date_initiated": "2026-04-15",
      "event_date_posted": "2026-06-01",
      "recall_status": "Open, Classified",
      "res_event_number": "98871",
      "product_code": "OCW",
      "k_numbers": [
        "K934738"
      ],
      "product_description": "Covidien EndoStitch\" Polysorb Single Use Loading Unit;\nProduct numbers: 170053 and 170071;",
      "code_info": "1. Product Number: 170053; UDI-DI: 10884521126732; UPN: 20884521126739; Lot number: J5L2332Y;\n\n2. Product Number: 170071; UDI-DI: 10884521126787; UPN: 20884521126784; Lot number: J5H2924Y;",
      "firm_fei_number": "1219930",
      "recalling_firm": "Covidien, LP",
      "address_1": "60 Middletown Ave",
      "city": "North Haven",
      "state": "CT",
      "postal_code": "06473-3908",
      "additional_info_contact": "Medtronic Technical Services\n800-255-6774",
      "reason_for_recall": "The presence of holes in the pouch may compromise the package s ability to maintain the sterile barrier and\nprotect the product from environmental exposure.",
      "root_cause_description": "Process control",
      "action": "On April 23, 2026 URGENT: VOLUNTARY MEDICAL DEVICE RECALL letters were sent to customers. \nCustomer actions:\n- Immediately identify and quarantine all unused impacted product listed above.\n- See Appendix A for guidance on identifying affected lots.\n- This notice needs to be passed on to all those who need to be aware within your organization or to any\norganization where the potentially affected devices have been transferred. Return all unused impacted product listed above to Medtronic.\nMedtronic Actions:\n- Medtronic representatives will assist customers with the return of affected product, upon request.\n- Medtronic representatives will work with customers to ensure replacement products are available to\navoid interruptions in patient care.",
      "product_quantity": "2448 units",
      "distribution_pattern": "Domestic: Nationwide distribution;\n\nInternational: Austria, Canada, Denmark, France, Italy;",
      "openfda": {
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        ],
        "registration_number": [
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        ],
        "device_name": "Endoscopic Tissue Approximation Device",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2"
      }
    }
  ]
}