{
  "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": "2026-09-10",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 13
    }
  },
  "results": [
    {
      "cfres_id": "218029",
      "product_res_number": "Z-1244-2026",
      "event_date_initiated": "2025-12-16",
      "event_date_posted": "2026-02-04",
      "recall_status": "Open, Classified",
      "res_event_number": "98255",
      "product_code": "HJK",
      "k_numbers": [
        "K050623"
      ],
      "product_description": "Volk Single Use Vitrectomy Lenses\n\n1. Flat Vitrectomy Lens, Catalog VFD\n2. Volk Magnifying Lens, Catalog VMD",
      "code_info": "1. Flat Vitrectomy Lens\nPouch UDI 810123482290\nBox UDI 810123482306\nLots 2410036\n2411020\n\n2. Volk Magnifying Lens\nPouch UDI 810123482825\nBox UDI 810123482832\nLot 2411019",
      "firm_fei_number": "3013002167",
      "recalling_firm": "Vortex Surgical Inc.",
      "address_1": "4 Research Park Dr Ste 124 4 Research Park Dr",
      "address_2": "Ste 124",
      "city": "Saint Charles",
      "state": "MO",
      "postal_code": "63304-5639",
      "additional_info_contact": "Andrew Ritts\n1-636-7784350",
      "reason_for_recall": "There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.",
      "root_cause_description": "Employee error",
      "action": "On December 16, 2025, the firm began notifying customers via \"URGENT: MEDICAL DEVICE RECALL\" letters. Customers were instructed to discontinue use of affected product and to return product for Vortex Surgical to evaluate the seals; use UPS account 23623Y to ship unused products to Vortex Surgical Inc for replacement or refund at: Attn: Andrew Ritts Recall Tyvek Seal, Vortex Surgical Inc., 4 Research Park Dr., Suite 124, St. Charles, MO 63304; complete and return the Acknowledgement and Receipt Form via mail or email to: ARitts@VortexSurgical.com.\n\nActions have been implemented to improve training of individuals associated with sealing and inspecting seals to prevent reoccurrence. The sealer associated with the issue is being updated to include a guard to prevent reoccurrence.\n\nIf you have any questions, contact the Director of Regulatory Affairs at 635-778-4350 or email to: ARitts@VortexSurgical.com from 8am to 5pm.",
      "product_quantity": "14,789 (8651 US; 6138 OUS)",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: AL, AR, AZ, CA, CT, FL, HI, IA, IL, IN, KY, MA, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, WA, WI, VA; and OUS (foreign) to countries of: Australia, Chile, China, France, Germany, India, Ireland, Italy, Japan, Korea, Mexico, Netherlands, Philippines, Poland, Puerto Rico, Spain, Switzerland, Taiwan, United Kingdom, Vietnam.",
      "openfda": {
        "k_number": [
          "K943125",
          "K914051",
          "K173944",
          "K863911",
          "K875330",
          "K014170",
          "K781960",
          "K971853",
          "K864418",
          "K862094",
          "K914117",
          "K030054",
          "K872855",
          "K142715",
          "K894421",
          "K050623",
          "K910231",
          "K862868",
          "K941420",
          "K872136",
          "K933264",
          "K875331",
          "K912366",
          "K033950",
          "K051630",
          "K012096",
          "K861648",
          "K201909",
          "K863027",
          "K896198",
          "K864304",
          "K875114",
          "K940107",
          "K875087",
          "K051103",
          "K151961",
          "K933976",
          "K022413",
          "K862728",
          "K871450",
          "K023221"
        ],
        "registration_number": [
          "",
          "1054811",
          "9615745",
          "2183744",
          "2027619",
          "3002807090",
          "3009337401",
          "3013002167",
          "2242450",
          "3004467263",
          "1000286794",
          "3004207966",
          "3015177648",
          "1000176188",
          "3035451914",
          "3014865",
          "2030624",
          "9611516",
          "1058584",
          "3009773841",
          "3002991496",
          "1225798",
          "3006142778",
          "3005941719",
          "3012712027",
          "1528142",
          "3004519921",
          "3012375451",
          "2939653"
        ],
        "fei_number": [
          "",
          "3002807111",
          "3006003617",
          "2183744",
          "2027619",
          "3005846326",
          "3000206435",
          "3000314405",
          "3009337401",
          "1000122772",
          "3013002167",
          "3002806863",
          "2242450",
          "3004467263",
          "1000286794",
          "3001595430",
          "3004207966",
          "3015177648",
          "1000176188",
          "3035451914",
          "3014865",
          "1000114185",
          "3009773841",
          "1000219637",
          "3002991496",
          "3006142778",
          "3012712027",
          "3012375451",
          "2939653"
        ],
        "device_name": "Lens, Contact, Polymethylmethacrylate, Diagnostic",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.1385",
        "device_class": "2"
      }
    }
  ]
}