{
  "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": "2026-07-08",
    "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": "95415",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Canada, Panama.",
      "recall_number": "Z-0158-2025",
      "product_description": "Medline brand medical procedure convenience kits, labeled as:    a) CONE BIOPSY PACK, REF DYNJ17534L;   b) BIOPSY TRAY, REF DYNJ43076A;   c) LOU LOOP RECORDER PACK, REF DYNJ49404C;   d) CT BIOPSY, REF DYNJ52666C;   e) BIOPSY KIT, REF DYNJ61130B;   f) ASPEN SOFT TISSUE PACK, REF DYNJ63165B;   g) BIOPSY TRAY FOAKS, REF DYNJ63575A;   h) CUSTOM SOFT TISSUE PACK, REF DYNJ66347A;   i) KWIK PACK, REF DYNJ67926B;   j) ESI TRAY, REF DYNJ68261B;   k) LARGE BIOPSY PACK NTX, REF DYNJ68393A;   l) LOOP KIT, REF DYNJ84129",
      "product_quantity": "2,426 units",
      "reason_for_recall": "It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.",
      "recall_initiation_date": "20240904",
      "center_classification_date": "20241023",
      "report_date": "20241030",
      "code_info": "a) REF DYNJ17534L, UDI/DI 40195327258253 (each), 10195327258252 (case), Lot Numbers:  23KBF936;  b) REF DYNJ43076A, UDI/DI 40195327080625 (each), 10195327080624 (case), Lot Numbers:  23LBI584;  c) REF DYNJ49404C, UDI/DI 40195327395453 (each), 10195327395452 (case), Lot Numbers:  23LBP833;  d) REF DYNJ52666C, UDI/DI 40193489452144 (each), 10193489452143 (case), Lot Numbers:  23LBN740;  e) REF DYNJ61130B, UDI/DI 40195327054589 (each), 10195327054588 (case), Lot Numbers:  23LBP401;  f) REF DYNJ63165B, UDI/DI 40193489461580 (each), 10193489461589 (case), Lot Numbers:  23KBD517;  g) REF DYNJ63575A, UDI/DI 40193489429337 (each), 10193489429336 (case), Lot Numbers:  23LBR787;  h) REF DYNJ66347A, UDI/DI 40193489884716 (each), 10193489884715 (case), Lot Numbers:  24ABA444;  i) REF DYNJ67926B, UDI/DI 40195327519514 (each), 10195327519513 (case), Lot Numbers:  23LBL347;  j) REF DYNJ68261B, UDI/DI 40195327513369 (each), 10195327513368 (case), Lot Numbers:  24ABA492;  k) REF DYNJ68393A, UDI/DI 40193489939997 (each), 10193489939996 (case), Lot Numbers:  23LBL431;  l) REF DYNJ84129, UDI/DI 40195327334544 (each), 10195327334543 (case), Lot Numbers:  23KBB926",
      "more_code_info": ""
    }
  ]
}