{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
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  },
  "results": [
    {
      "cfres_id": "211377",
      "product_res_number": "Z-0783-2025",
      "event_date_initiated": "2024-11-21",
      "event_date_posted": "2024-12-30",
      "recall_status": "Open, Classified",
      "res_event_number": "95852",
      "product_code": "FDE",
      "product_description": "Medline custom medical procedure kits labeled as:  \n1) FREE FLAP BASIC SET-UP PK, REF DYNJ0991320J; \n2) MVFF/FIBU #54-RF, REF DYNJ21927R; \n3) FUNCTIONAL SINUS ENDOSCOPY, REF DYNJ40406A; \n4) DR GOLDSTEIN ACCESSORY PACK, REF DYNJ51818F; \n5) ENDOSCOPIC SKULL BASE, REF DYNJ58648F; \n6) DIEP FLAP, REF DYNJ66867A; \n7) KIT FREE FLAP MOSES, REF DYNJ905366A; \n8) FREE FLAP, REF DYNJ905634B; \n9) ROBOTIC THORACIC, REF DYNJ907817; \n10) TRANSPHENOIDAL, REF DYNJ908165; \n11) METREX, REF DYNJ910072; \n12) DIEP FLAP, REF DYNJ910120A.",
      "code_info": "1) REF DYNJ0991320J, UDI/DI 10193489686661 (EA) 40193489686662 (CS), Lot Numbers:  19EKB321, 19GKD099, 19JKA065, 19LKB378, 20DKA223, 20EKA239, 20FKB859, 20GKA150, 20HKB438, 21ALA327; \n\n2) REF DYNJ21927R, UDI/DI 10195327104733 (EA) 40195327104734 (CS), Lot Numbers:  23JBK732; \n\n3) REF DYNJ40406A, UDI/DI 10889942215904 (EA) 40889942215905 (CS), Lot Numbers:  23HBD879; \n\n4) REF DYNJ51818F, UDI/DI 10889942741601 (EA) 40889942741602 (CS), Lot Numbers:  19BBA689, 19CBD918; \n\n5) REF DYNJ58648F, UDI/DI 10193489884449 (EA) 40193489884440 (CS), Lot Numbers:  21EMF317; \n\n6) REF DYNJ66867A, UDI/DI 10193489986235 (EA) 40193489986236 (CS), Lot Numbers:  22ABE990, 22FBV019, 22KBK097, 22NBE822, 23DBG870, 23EBR848, 23FBA588, 23HBX771, 23IBW237, 23KBC127, 23KBT141; \n\n7) REF DYNJ905366A, UDI/DI 10193489759372 (EA) 40193489759373 (CS), Lot Numbers:  19LBL885, 20BBJ487, 20CBF683, 20FBC462, 20HBN061, 21CBU514, 21DBO189, 21EBI475, 21EBN240, 21FBT699, 21FBT700, 21FBT702, 21KBN245; \n\n8) REF DYNJ905634B, UDI/DI 10193489633924 (EA) 40193489633925 (CS), Lot Numbers:  19EBD435, 19EBL594, 19FBG295, 19GBR466, 19GBS384, 20FBS328, 21EBM629, 21FBP379, 21FBT340, 22GMH714, 23CMF811, 23DMA128, 23JMD524, 24AMJ344, 24BME042, 24DMB281, 24EMI831, 24FMC477; \n\n9) REF DYNJ907817, UDI/DI 10193489887167 (EA) 40193489887168 (CS), Lot Numbers:  21EBC333; \n\n10) REF DYNJ908165, UDI/DI 10193489992014 (EA) 40193489992015 (CS), Lot Numbers:  22CLA236, 22CLA782, 22FLA058, 22JBI497, 23BBD054, 23BBF440, 23BBG445, 23BBL712, 23FBA102, 23IBO315, 23KBH043, 23KBH076, 23LBG978; \n\n11) REF DYNJ910072, UDI/DI 10195327567538 (EA) 40195327567539 (CS), Lot Numbers:  24CBL710; \n\n12) REF DYNJ910120A, UDI/DI 10195327689872 (EA) 40195327689873 (CS), Lot Numbers:  24HMK254.",
      "firm_fei_number": "1417592",
      "recalling_firm": "MEDLINE INDUSTRIES, LP - Northfield",
      "address_1": "3 Lakes Dr",
      "city": "Northfield",
      "state": "IL",
      "postal_code": "60093-2753",
      "additional_info_contact": "Haley Barclay\n866-359-1704",
      "reason_for_recall": "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email.  The notice explained the issue, potential risk to health, and requested that the affected product be quarantined.  Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.",
      "product_quantity": "943 units",
      "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of UAE, and Canada.",
      "openfda": {
        "k_number": [
          "K912443",
          "K942677",
          "K955717",
          "K950924"
        ],
        "device_name": "Laparoscopy Kit",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.1500",
        "device_class": "2",
        "registration_number": [
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