{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Boston",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92481",
      "recalling_firm": "TEI Biosciences, Inc.",
      "address_1": "7 Elkins St",
      "address_2": "N/A",
      "postal_code": "02127-1601",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: Nationwide Distribution.",
      "recall_number": "Z-2075-2023",
      "product_description": "SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0.5 cm, and 10x25 cm Fenestrated.",
      "product_quantity": "5,664 units",
      "reason_for_recall": "Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.",
      "recall_initiation_date": "20230523",
      "center_classification_date": "20230703",
      "report_date": "20230712",
      "code_info": "Item No. (UDI-DI): 606-400-002 (10381780113201), 606-400-004 (10381780113218), 606-400-006 (10381780113225), 606-400-009 (10381780113232), 606-400-016 (10381780113249), 606-400-017 (10381780113256), 606-400-018 (10381780113263), 606-403-001 (10381780113270), and 606-404-001 (10381780113287)."
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}