{
  "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": "221124",
      "product_res_number": "Z-2649-2026",
      "event_date_initiated": "2026-06-01",
      "event_date_posted": "2026-07-01",
      "recall_status": "Open, Classified",
      "res_event_number": "99239",
      "product_code": "JAD",
      "k_numbers": [
        "K121653"
      ],
      "product_description": "Zeiss Intrabeam Spherical Applicator 1.5 cm\nREF:304534-6000-557",
      "code_info": "UDI: (01)04049539101563\nBatch no: A0002\n\nSerial numbers:\nUS - A63141, A63086\nOUS (Outside the US) - A63085, A63096, A63101, A63102, A63105, A63107, A63108, A63109, A63110,\nA63112, A6313",
      "firm_fei_number": "3003481798",
      "recalling_firm": "Carl Zeiss Meditec AG",
      "address_1": "Rudolf-Eber-Str. 11 11 rudolf-eber-str.",
      "city": "Oberkochen",
      "country": "Germany",
      "additional_info_contact": "Lucia Puettmann\n497364-20-2555",
      "reason_for_recall": "Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.",
      "root_cause_description": "Employee error",
      "action": "On June 12, 2026, Carl Zeiss Meditech issued a Urgent Medical Device Recall to affected consignees via FedEx Priority. Carl Zeiss ask consignees to take the following actions:\n\n1. Immediately discontinue use of any affected applicator identified in this notice and segregate/quarantine it to prevent further use.\n2. Complete, sign, and return the attached Acknowledgement and Receipt Form to CZMUI in accordance with the instructions provided on the form.\n3. Once the Acknowledgement and Receipt Form has been received by CZMUI, then a member of our service team will contact you to schedule the replacement of your applicator and collect the recalled applicator from you.\n4. This recall letter should be shared with anyone who needs to be aware within your organization and forwarded to any organization where potentially affected devices have been transferred.",
      "product_quantity": "13 units",
      "distribution_pattern": "Worldwide - US Nationwide distribution in the state and territories of Florida and Puerto Rico. The countries of China, Germany, Ecuador, Spain, France, Malaysia, Philippines, Poland, and Romania.",
      "openfda": {
        "k_number": [
          "K250692",
          "K213942",
          "K871810",
          "K110590",
          "K121653",
          "K230611",
          "K861431",
          "K844424",
          "K962613",
          "K241174",
          "K190255",
          "K964947",
          "K811528",
          "K083734",
          "K935209",
          "K781084",
          "K780278",
          "K050843",
          "K992577",
          "K971074",
          "K904005",
          "K173425",
          "K072616",
          "K111299",
          "K131582",
          "K833560",
          "K771817",
          "K123985",
          "K072683",
          "K903377",
          "K874214",
          "K090914",
          "K854609",
          "K172080",
          "K980526",
          "K132092",
          "K964952",
          "K090584",
          "K063456",
          "K780157",
          "K153570",
          "K182641",
          "K162568",
          "K130549",
          "K973315",
          "K894683",
          "K141343",
          "K051055",
          "K813439",
          "K923584",
          "K122951",
          "K882484",
          "K150037"
        ],
        "registration_number": [
          "2953359",
          "3006017180",
          "2320968",
          "1181047",
          "3009539885",
          "3036107971",
          "3032638959",
          "3010653929",
          "3008513398",
          "3005770916",
          "3030230020",
          "3015232217",
          "3009732568",
          "3009039068",
          "9615010",
          "9611894",
          "3004561814",
          "1219183",
          "3023344262",
          "3005562917"
        ],
        "fei_number": [
          "3003318268",
          "3006017180",
          "1181047",
          "3002807741",
          "3009539885",
          "3036107971",
          "3032638959",
          "3010653929",
          "3008513398",
          "3005770916",
          "3030230020",
          "3003481798",
          "3009732568",
          "3009039068",
          "3015232217",
          "3004561814",
          "1219183",
          "3023344262",
          "3005562917",
          "3000215205"
        ],
        "device_name": "System, Therapeutic, X-Ray",
        "medical_specialty_description": "Radiology",
        "regulation_number": "892.5900",
        "device_class": "2"
      }
    }
  ]
}