{
  "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-2170-2023",
      "product_description": "Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following:  a)\tBREAST BIOPSY KIT, Model Number DYNDA1224B;   b)\tU/S CORE BIOPSY KIT, Model Number DYNDH1121C;   c)\tBIOPSY PACK, Model Number DYNDH1124;   d)\tREVAMP BIOPSY TRAY, Model Number DYNDH1147A;   e)\tBREAST BIOPSY TRAY, Model Number DYNDH1266;   f)\tBREAST BIOPSY TRAY, Model Number DYNDH1345A;   g)\tULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A;   h)\tBASIC BIOPSY TRAY, Model Number DYNDH1534;   i)\tULTRASOUND BIOPSY, Model Number DYNDH1542B;   j)\tCABARRUS BIOPSY TRAY, Model Number DYNDH1670;   k)\tBREAST BIOPSY TRAY, Model Number DYNDH1677;   l)\tNORTH PARK BIOPSY TRAY, Model Number DYNDH1748;   m)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750;   n)\tSOFT TISSUE BIOPSY, Model Number DYNDH1750A;   o)\tUL BIOPSY TRAY, Model Number DYNDH1778;   p)\tBREAST BIOPSY KIT, Model Number DYNDH1822;   q)\tULTRASOUND BIOPSY, Model Number DYNDH1828;   r)\tBIOPSY PACK-LF, Model Number DYNJ0747885G;   s)\tBIOPSY TRAY, Model Number DYNJ34637G;   t)\tIGT BIOPSY PACK-LF, Model Number DYNJ38616A;   u)\tBIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A;   v)\tCORE BIOPSY PACK-LF, Model Number DYNJ42752A;   w)\tBIOPSY TRAY, Model Number DYNJ43076;   x)\tBIOPSY TRAY, Model Number DYNJ43076A;   y)\tBIOPSY PACK, Model Number DYNJ50485;   z)\tABLATION/DRAINAGE PACK, Model Number DYNJ53658B;   aa)\tBIOPSY RAD CT, Model Number DYNJ59752A;   bb)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992B;   cc)\tUS BREAST BIOPSY PACK, Model Number DYNJ61992C;   dd)\tBIOPSY TRAY, Model Number DYNJ62690;   ee)\tIR BIOPSY PACK, Model Number DYNJ63688A;   ff)\tIR BIOPSY PACK, Model Number DYNJ63688B;   gg)\tIR BIOPSY PACK, Model Number DYNJ63688C;   hh)\tIR BIOPSY PACK, Model Number DYNJ63688G;   ii)\tIR BIOPSY PACK, Model Number DYNJ63688I;   jj)\tINSERTION PACK, Model Number DYNJ83149;   kk)\tGENERAL BIOPSY PACK, Model Number P365500;   ll)\tRENAL BIOPSY TRAY, Model Number SPEC0168;",
      "product_quantity": "47185 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 DYNDA1224B, UDI/DI (EA) 10193489468519, UDI/DI (CS) 40193489468510;  b) Model Number DYNDH1121C, UDI/DI (EA) 10193489468656, UDI/DI (CS) 40193489468657;  c) Model Number DYNDH1124, UDI/DI (EA) 10889942303274, UDI/DI (CS) 40889942303275;  d) Model Number DYNDH1147A, UDI/DI (EA) 10193489348798, UDI/DI (CS) 40193489348799;  e) Model Number DYNDH1266, UDI/DI (EA) 10889942670451, UDI/DI (CS) 40889942670452;  f) Model Number DYNDH1345A, UDI/DI (EA) 10888277732933, UDI/DI (CS) 40888277732934;  g) Model Number DYNDH1496A, UDI/DI (EA) 10193489825312, UDI/DI (CS) 40193489825313;  h) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 40193489197083;  i) Model Number DYNDH1542B, UDI/DI (EA) 10195327251475, UDI/DI (CS) 40195327251476;  j) Model Number DYNDH1670, UDI/DI (EA) 10195327010683, UDI/DI (CS) 40195327010684;  k) Model Number DYNDH1677, UDI/DI (EA) 10195327044480, UDI/DI (CS) 40195327044481;  l) Model Number DYNDH1748, UDI/DI (EA) 10195327164744, UDI/DI (CS) 40195327164745;  m) Model Number DYNDH1750, UDI/DI (EA) 10195327166427, UDI/DI (CS) 40195327166428;  n) Model Number DYNDH1750A, UDI/DI (EA) 10195327337872, UDI/DI (CS) 40195327337873;  o) Model Number DYNDH1778, UDI/DI (EA) 10195327228477, UDI/DI (CS) 40195327228478;  p) Model Number DYNDH1822, UDI/DI (EA) 10195327292294, UDI/DI (CS) 40195327292295;  q) Model Number DYNDH1828, UDI/DI (EA) 10195327311308, UDI/DI (CS) 40195327311309;  r) Model Number DYNJ0747885G, UDI/DI (EA) 10195327088729, UDI/DI (CS) 40195327088720;  s) Model Number DYNJ34637G, UDI/DI (EA) 10193489368802, UDI/DI (CS) 40193489368803;  t) Model Number DYNJ38616A, UDI/DI (EA) 10884389755952, UDI/DI (CS) 40884389755953;  u) Model Number DYNJ42307A, UDI/DI (EA) 10888277298750, UDI/DI (CS) 40888277298751;  v) Model Number DYNJ42752A, UDI/DI (EA) 10889942326099, UDI/DI (CS) 40889942326090;  w) Model Number DYNJ43076, UDI/DI (EA) 10888277024533, UDI/DI (CS) 40888277024534;  x) Model Number DYNJ43076A, UDI/DI (EA) 10195327080624, UDI/DI (CS) 40195327080625;  y) Model Number DYNJ50485, UDI/DI (EA) 10888277992795, UDI/DI (CS) 40888277992796;  z) Model Number DYNJ53658B, UDI/DI (EA) 10195327088705, UDI/DI (CS) 40195327088706;  aa) Model Number DYNJ59752A, UDI/DI (EA) 10193489598575, UDI/DI (CS) 40193489598576;  bb) Model Number DYNJ61992B, UDI/DI (EA) 10195327292652, UDI/DI (CS) 40195327292653;  cc) Model Number DYNJ61992C, UDI/DI (EA) 10195327406592, UDI/DI (CS) 40195327406593;  dd) Model Number DYNJ62690, UDI/DI (EA) 10193489682267, UDI/DI (CS) 40193489682268;  ee) Model Number DYNJ63688A, UDI/DI (EA) 10193489326451, UDI/DI (CS) 40193489326452;  ff) Model Number DYNJ63688B, UDI/DI (EA) 10193489405590, UDI/DI (CS) 40193489405591;  gg) Model Number DYNJ63688C, UDI/DI (EA) 10193489432282, UDI/DI (CS) 40193489432283;  hh) Model Number DYNJ63688G, UDI/DI (EA) 10193489897197, UDI/DI (CS) 40193489897198;  ii) Model Number DYNJ63688I, UDI/DI (EA) 10195327037239, UDI/DI (CS) 40195327037230;  jj) Model Number DYNJ83149, UDI/DI (EA) 10195327235710, UDI/DI (CS) 40195327235711;  kk) Model Number P365500, UDI/DI (EA) 10889942141852, UDI/DI (CS) 40889942141853;  ll) Model Number SPEC0168, UDI/DI (EA) 10884389869864, UDI/DI (CS) 40884389869865;",
      "more_code_info": ""
    }
  ]
}