{
  "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-2069-2023",
      "product_description": "SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x20 cm, 1.0 13x25 cm, 1.0 4x16 cm, 1.0 3x3 cm, 1.0 4x7 cm, 1.0 4x12 cm, 1.0 6x16 cm, 1.0 25x40 cm, 1.0 20 x 30 cm, 1.0 8x16 cm, 1.0 4x7 cm Thin, 1.0 5x6 cm Thin, 1.0 3x3 cm Thin, 1.0 0.3x25 cm, 1.0 0.6x25 cm, 1.0 1x25 cm.",
      "product_quantity": "14,535 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): 606-001-002 (10381780112617), 606-001-004 (10381780112624), 606-001-005 (10381780112631), 606-001-006 (10381780112648), 606-001-007 (10381780112655), 606-001-008 (10381780112662), 606-001-009 (10381780112679), 606-001-010 (10381780112686), 606-001-012 (10381780112693), 606-001-013 (10381780112709), 606-001-014 (10381780112716), 606-001-015 (10381780112723), 606-001-016 (10381780112730), 606-001-017 (10381780112747), 606-001-018 (10381780112754), 606-002-002 (10381780112761), 606-002-003 (10381780112778), 606-002-005 (10381780112785), 606-003-001 (10381780112792), 606-003-002 (10381780112808), 606-003-003 (10381780112815)."
    }
  ]
}