{
  "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": "2026-08-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Billings",
      "state": "MT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "99323",
      "recalling_firm": "Windstone Medical Packaging, Inc.",
      "address_1": "1602 4th Ave N",
      "address_2": "N/A",
      "postal_code": "59101-1521",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.",
      "recall_number": "Z-2799-2026",
      "product_description": "AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)\tENT Pack, Part Number AMS10411B;   2)\tENT Pack, Part Number AMS10411C;   3)\tRhinoplasty Pack, Part Number AMS11963A;   4)\tSpine Pack, Part Number AMS12636C;   5)\tLumbar Lami Pack, Part Number AMS12731;   6)\tSeptoplasty Pack, Part Number AMS13150;   7)\tSeptoplasty Pack, Part Number AMS13150A;   8)\tSeptoplasty Pack, Part Number AMS13150B;   9)\tRhinoplasty Pack, Part Number AMS14496A;   10)\tRhinoplasty Pack, Part Number AMS14496B;   11)\tRhinoplasty Pack, Part Number AMS14496C;   12)\tLaryngoscopy Pack, Part Number AMS14736;   13)\tNasal and Sinus Pack, Part Number AMS16417;   14)\tMajor Pack, Part Number AMS16586;   15)\tMajor Pack, Part Number AMS16586A;   16)\tNasal and Sinus Pack, Part Number AMS7619A;   17)\tSinus Pack, Part Number AMS7819A.",
      "product_quantity": "465 units",
      "reason_for_recall": "The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.",
      "recall_initiation_date": "20260608",
      "center_classification_date": "20260724",
      "report_date": "20260805",
      "code_info": "1) Pack Number AMS10411B, UDI B098AMS10411B0, Lot Numbers:  219316, 221418, 225796, 227963, 229410, 231465, 232835, 234875, 236009.   2) Pack Number AMS10411C, UDI B098AMS10411C0, Lot Numbers:  237159, 239012.   3) Pack Number AMS11963A, UDI B098AMS11963A0, Lot Numbers:  219232, 221841, 231180, 233233, 235232, 237047, 239415.   4) Pack Number AMS12636C, UDI B098AMS12636C0, Lot Numbers:  216052, 216353, 219607, 222572, 227336, 228169, 232135, 232908, 236235, 242190.   5) Pack Number AMS12731, UDI B098AMS127310, Lot Numbers:  211494, 219640, 224583, 225855, 226678, 228322, 231368, 241824.   6) Pack Number AMS13150, UDI B098AMS131500, Lot Numbers:  172113, 190090, 196504, 197866, 199463, 199844, 201971.   7) Pack Number AMS13150A, UDI B098AMS13150A0, Lot Numbers:  202549, 204081, 209263, 210230, 211511, 213173, 215672.   8) Pack Number AMS13150B, UDI B098AMS13150B0, Lot Numbers:  216273, 216809, 218664, 219473, 222602, 224670, 225793, 227885, 229995, 232849, 234167, 235630, 236695, 237697, 239909, 241667.   9) Pack Number AMS14496A, UDI B098AMS14496A0, Lot Numbers:  207772, 219739.   10) Pack Number AMS14496B, UDI B098AMS14496B0, Lot Numbers:  223681, 224699, 226316, 227598.   11) Pack Number AMS14496C, UDI B098AMS14496C0, Lot Numbers:  231376, 237310.   12) Pack Number AMS14736, UDI B098AMS147360, Lot Numbers:  192735, 204268, 222714, 226621.   13) Pack Number AMS16417, UDI B098AMS164170, Lot Numbers:  217216, 219433, 219463, 229357, 235439, 237701, 241666.   14) Pack Number AMS16586, UDI B098AMS16586, Lot Numbers:  229154, 230255.   15) Pack Number AMS16586A, UDI B098AMS16586A0, Lot Numbers:  233268, 233269, 233688, 233689, 235659, 236978, 237621, 238623, 239249, 241987.   16) Pack Number AMS7619A, UDI B098AMS7619A0, Lot Numbers:  176227, 179354, 184684, 186205, 187036, 188521, 189734, 191564, 195253, 197149, 202475, 202880, 205844, 206922, 210055, 211416, 212266, 215112, 217611, 218240, 219633, 221172, 223315, 225142, 226992, 229948, 231847, 232319, 234276, 235042, 239240, 241617.   17) Pack Number AMS7819A, UDI B098AMS7819A0, Lot Numbers:  173334, 176639, 177152, 180388, 182683, 186406, 190810, 192202, 192848, 194365, 197188, 199488, 202783, 205388, 206750, 211253, 212412, 215250, 216089, 217246, 220359, 223776, 225483, 226654, 229721, 232212, 233317, 233852, 236921, 238278, 242389."
    }
  ]
}