{
  "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": "Northfield",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92466",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "address_2": "N/A",
      "postal_code": "60093-2753",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.",
      "recall_number": "Z-2169-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tFETAL SURGERY CDS-LF, Model Number CDS840214Q;   b)\tMINOR PROCEDURE TRAY, Model Number DYNDA2418;   c)\tCLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J;   d)\tBARIATRIC PACK, Model Number DYNJ24459P;   e)\tABLATION PACK, Model Number DYNJ40629B;   f)\tENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B;   g)\tIR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C;   h)\tEVLT SURGICAL PACK, Model Number DYNJ48520;   i)\tMAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A;   j)\tLAPAROSCOPY PACK, Model Number DYNJ59813;   k)\tPORT PACK, Model Number DYNJ61747C;   l)\tRR-BRACHY PACK, Model Number DYNJ68027A;   m)\tAV FISTULA PACK, Model Number DYNJ81410B;   n)\tECMO PACK-LF, Model Number DYNJ82517;   o)\tSYNERGY PROCEDURE PACK, Model Number DYNJ83966;   p)\tMINOR, Model Number DYNJ906915;   q)\tPROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C;   r)\tULTRASOUND PACK-LF, Model Number PHS751646C;   s)\tULTRASOUND PACK-LF, Model Number PHS751646D;",
      "product_quantity": "770147 units",
      "reason_for_recall": "Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.",
      "recall_initiation_date": "20230518",
      "center_classification_date": "20230720",
      "report_date": "20230726",
      "code_info": "all lots within expiry, distributed from Medline between December 2017 - May 2023:   a) Model Number CDS840214Q, UDI/DI (EA) 10195327289904, UDI/DI (CS) 40195327289905;  b) Model Number DYNDA2418, UDI/DI (EA) 10193489378214, UDI/DI (CS) 40193489378215;  c) Model Number DYNJ0365463J, UDI/DI (EA) 10193489783872, UDI/DI (CS) 40193489783873;  d) Model Number DYNJ24459P, UDI/DI (EA) 10193489355345, UDI/DI (CS) 40193489355346;  e) Model Number DYNJ40629B, UDI/DI (EA) 10888277778696, UDI/DI (CS) 40888277778697;  f) Model Number DYNJ44210B, UDI/DI (EA) 10193489306859, UDI/DI (CS) 40193489306850;  g) Model Number DYNJ47716C, UDI/DI (EA) 10195327355296, UDI/DI (CS) 40195327355297;  h) Model Number DYNJ48520, UDI/DI (EA) 10888277903463, UDI/DI (CS) 40888277903464;  i) Model Number DYNJ53059A, UDI/DI (EA) 10889942415113, UDI/DI (CS) 40889942415114;  j) Model Number DYNJ59813, UDI/DI (EA) 10888277786455, UDI/DI (CS) 40888277786456;  k) Model Number DYNJ61747C, UDI/DI (EA) 10193489365030, UDI/DI (CS) 40193489365031;  l) Model Number DYNJ68027A, UDI/DI (EA) 10195327351144, UDI/DI (CS) 40195327351145;  m) Model Number DYNJ81410B, UDI/DI (EA) 10195327320829, UDI/DI (CS) 40195327320820;  n) Model Number DYNJ82517, UDI/DI (EA) 10195327198640, UDI/DI (CS) 40195327198641;  o) Model Number DYNJ83966, UDI/DI (EA) 10195327320423, UDI/DI (CS) 40195327320424;  p) Model Number DYNJ906915, UDI/DI (EA) 10193489280371, UDI/DI (CS) 40193489280372;  q) Model Number DYNJ908046C, UDI/DI (EA) 10195327313494, UDI/DI (CS) 40195327313495;  r) Model Number PHS751646C, UDI/DI (EA) 10889942245352, UDI/DI (CS) 40889942245353;  s) Model Number PHS751646D, UDI/DI (EA) 10195327196806, UDI/DI (CS) 40195327196807;",
      "more_code_info": ""
    }
  ]
}