{
  "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
    }
  },
  "results": [
    {
      "cfres_id": "210790",
      "product_res_number": "Z-0623-2025",
      "event_date_initiated": "2024-10-09",
      "event_date_posted": "2024-12-05",
      "recall_status": "Open, Classified",
      "res_event_number": "95621",
      "product_code": "OFT",
      "product_description": "MEDLINE medical convenience kits labeled as:  \n1) ACETABULAR PACK-LF, REF DYNJ0572894I; \n2) LOCAL BASIC, REF DYNJ34418L; \n3) LOCAL BASIC, REF DYNJ34418M; \n4) MINI LOCAL, REF DYNJ900287D",
      "code_info": "1) REF DYNJ0572894I, UDI/DI 10195327045975 (each) 40195327045976 (case), Lot Numbers: 22EBV549, 22FBV442, 23ABU908, 22LBG711, 23CBJ089, 23BBM090, 23GBS959, 23JBG841; \n\n2) REF DYNJ34418L, UDI/DI 10193489969276 (each) 40193489969277 (case), Lot Numbers:  23CBT026, 23ABO601; \n\n3) REF DYNJ34418M, UDI/DI 10195327384371 (each) 40195327384372 (case), Lot Numbers:  23GBA504; \n\n4) REF DYNJ900287D, UDI/DI 10193489798289 (each) 40193489798280 (case), Lot Numbers:  23BBT640, 23FBF622, 23GBL588, 23FBV779, 23EBF038,",
      "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": "Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.",
      "root_cause_description": "Under Investigation by firm",
      "action": "Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 10/11/2024 via mail and email.  The notice explained the problem with the Stryker component, potential risk, requested the kits be quarantined pending additional labeling and o respond through their portal:  https://recalls.medline.com.  Once the response is received, Medline will provide additional labeling to be applied to the affected kits which states the following:  \"Attention: R-24-219, This kit contains a recalled item, STRYKER SafeAir Smoke Evacuation Pencil, VPN: 0703-047-000, 0703-047-001, 0703-047-002, 0703-046-000, 0703-046-001, 0703-046-002.  DO NOT USE THIS COMPONENT.  The rest of the kit may be used.  Please remove this item only and replace with product from supply.  *Do not cover or remove this sticker*\".\nThose further distributing the product were directed to notify their customers.",
      "product_quantity": "182 units",
      "distribution_pattern": "US Nationwide distribution.",
      "openfda": {
        "registration_number": [
          "1223004",
          "3005595283",
          "3007329020",
          "1643817",
          "3009888344",
          "1030451",
          "3004111573",
          "3045816907",
          "1423537",
          "3013764800",
          "2523676",
          "1928237",
          "1423395",
          "9616088",
          "2521402",
          "3035642068",
          "1018470",
          "3005012805",
          "1061927",
          "3015173212",
          "1061124",
          "3004122598",
          "3045816902",
          "3006450239"
        ],
        "fei_number": [
          "3000203000",
          "3000717925",
          "3005595283",
          "3002902735",
          "3001236905",
          "1000120555",
          "3007329020",
          "1643817",
          "3009888344",
          "1030451",
          "3004111573",
          "3045816907",
          "3013764800",
          "2523676",
          "1928237",
          "2521402",
          "3035642068",
          "1000512168",
          "1018470",
          "3005012805",
          "3015173212",
          "3004122598",
          "3045816902",
          "3006450239"
        ],
        "device_name": "Spinal Epidural Anesthesia Kit",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5120",
        "device_class": "2"
      }
    }
  ]
}