{
  "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": "Ongoing",
      "city": "Bochum",
      "state": "N/A",
      "country": "Germany",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88213",
      "recalling_firm": "INNOVATIVE TOMOGRAPHY PRODUCT GMBH",
      "address_1": "Universitatsstr. 136",
      "address_2": "N/A",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state of CA.",
      "recall_number": "Z-2163-2021",
      "product_description": "Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:     Article no. KIR 23/05, Length 50 mm, Diameter 23 G (0.6 mm);  Article no. KIR 23/05N, Length 50 mm, Diameter\t23 G (0.6 mm);   Article no. KIR 23/07, Length 75 mm, Diameter 23 G (0.6 mm);  Article no. KIR 23/07N, Length 70 mm, Diameter\t23 G (0.6 mm);  Article no. KIR 23/10, Length 100 mm, Diameter 23G (0,6mm);  Article no. KIR 23/15, Length 150 mm, Diameter\t23 G (0.6 mm);  Article no. KIR 21/10, Length 100 mm, Diameter\t21 G (0.8 mm);  Article no. KIR 21/12, Length 120 mm, Diameter\t21 G (0.8 mm);  Article no. KIR 21/15, Length 150 mm, Diameter\t21 G (0.8 mm);  Article no. KIR 21/20, Length 200 mm, Diameter\t21 G (0.8 mm);  Article no. KIR 17/15, Length 150 mm, Diameter\t17 G (1.40mm)  Article no. KIR 17/15:45, Length 150 mm, Diameter 17 G (1.40mm)      *NOT DISTRIBUTED WITHIN THE US",
      "product_quantity": "N/A",
      "reason_for_recall": "Sterility Assurance; Coaxial Interventional Needle labeled as sterile may not have been adequately sterilized",
      "recall_initiation_date": "20210421",
      "center_classification_date": "20210729",
      "report_date": "20210804",
      "code_info": "Affected Lot Numbers:    KIR 23/05: LOT: 2516, 5016, 1417, 0718, 3318, 4318, 3819, 1520;   KIR 23/05N: LOT: 0717, 5117, 0518, 4318, 1520;   KIR 23/07: LOT: 2516, 4216, 3617, 0718, 3318, 4318, 2119, 3819, 1520, 3320, 4420;   KIR 23/07N: LOT: 2916, 4516, 5016, 0717, 1618, 4318, 3819, 1520, 5220;   KIR 23/10: LOT: 2016, 2916, 4016, 5016, 0417, 0817, 0917, 1417, 2117A, 2117B, 3917, 4217, 4317, 4517,1618, 4118, 3318, 4818, 4318, 0319, 3319, 4119, 4619, 0520, 1620, 4420, 5220  KIR 23/15: LOT: 1417, 0418, 3319, 2420;   KIR 21/10: LOT: 2916, 4016, 1417, 2117A, 2117B, 0418, 4318, 0719, 2119, 3519, 4619,1020, 1620, 5220;   KIR 21/12: LOT: 2116, 0717, 1618, 2119, 4619, 1020, 3820;   KIR 21/15: LOT: 3416, 0717, 1417, 0418, 3318, 4318, 3819, 1020, 3820;   KIR 21/20: LOT: 3617, 1020;   KIR17/15: LOT: 2417, 5117, 0918;   KIR17/15:45: LOT: 3616, 4216, 2317, 5117, 0918, 3919, 2720;"
    }
  ]
}