{
  "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-2162-2021",
      "product_description": "Coaxial Interventional Needle, ITP innotom.com, CE 0297, STERILE EO for the following article numbers:     Article no. KIM 22/05, Length 50 mm, diameter 22G/0,7 mm;   Article no. KIM 22/07,Length 75 mm, diameter 22 G (0.7 mm);  Article no. KIM 22/10, Length 100 mm, diameter 22 G (0.7 mm);  Article no. KIM 20/15, Length 150 mm, diameter\t20 G (0.9 mm);  Article no. KIM 18/10, Length 100 mm, diameter 18 G (1.25 mm);  Article no. KIM 18/10T, Length 100 mm, diameter 18 G (1.25 mm);   Article no. KIM 18/15, Length 150 mm, diameter 18 G (1.25 mm);    Article no. KIM 18/15T, Length 150 mm,  diameter 18 G (1.25 mm);  Article No. KIM 18/20, Length 200 mm, diameter 18G/1.27mm,   Article no. KIM 13/04T, Length 44 mm, diameter 13 G (2.40 mm);  Article no. KIM 13/09T, Length 94 mm , diameter 13 G (2.40 mm);  Article no. KIM 13/14T, Length 144 mm, diameter 13 G (2.40 mm);  Article no. KIM 15/04T, Length 44 mm, diameter 15 G (1.95 mm);  Article no. KIM 15/09T, Length 94 mm, diameter 15 G (1.95 mm);  Article no. KIM 15/14T, Length 144 mm, diameter 15 G (1.95 mm);  Article no. KIM 16/04T,Length 44 mm, diameter 16 G (1.60 mm);  Article no. KIM 16/09T, Length 94 mm, diameter 16 G (1.60 mm);  Article no. KIM 16/14T, Length 144 mm, diameter 16 G (1.60 mm);  Article no. KIM 14/20T, Length 200 mm, Diameter 14 G (2.1 mm)",
      "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:    KIM 22/05: LOT: 3416, 5016, 0717, 1417, 4117, 4217, 0418, 2818, 2119, 4619A, 3819, 0220A, 0220B, 0220C, 2420, 3820;   KIM 22/07: LOT: 4216, 0717, 1417, 4918, 2119, 4619A, 4319, 0220A, 0220B, 3820;   KIM 22/10: LOT: 3616, 5016, 0717, 1417, 0418, 1118, 2818, 2119, 2419, 4619A, 0220A, 0220B, 0220C, 4319, 1220, 1020, 2720, 3520;   KIM 22/15: LOT: 1417, 2118,4319;   KIM 20/10: LOT: 4318;   KIM 20/15: LOT: 4318;   KIM 18/10: LOT: 0717, 4318;   KIM 18/10T: LOT: 0217;   KIM 18/15: LOT: 0717, 4318, 0920;   KIM 18/15T: LOT: 4318;   KIM 18/20: LOT: 4318;   KIM 13/04T: LOT: 0817, 4318;   KIM 13/09T: LOT: 0817, 4318;   KIM 13/14T: LOT: 0817, 4318;   KIM 15/04T: LOT: 2818;   KIM 15/09T: LOT: 2818;   KIM 15/14T: LOT: 2818;   KIM 16/04T: LOT: 2818, 4820;   KIM 16/09T: LOT: 2818, 4820, 5020;   KIM 16/14T: LOT: 2818, 4820;   KIM 14/20T: LOT: 2419;"
    }
  ]
}