{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Vortex Surgical, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/vortex-surgical-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/vortex-surgical-inc",
    "json_url": "https://devicerts.com/manufacturers/vortex-surgical-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/vortex-surgical-inc.md",
    "publisher": "deviCERTS (devicerts.com)",
    "data_sources": [
      {
        "registry": "EUDAMED",
        "url": "https://ec.europa.eu/tools/eudamed"
      },
      {
        "registry": "FDA GUDID",
        "url": "https://accessgudid.nlm.nih.gov/"
      },
      {
        "registry": "FDA recalls",
        "url": "https://open.fda.gov/apis/device/recall/"
      }
    ],
    "eudamed_record_synced": "2026-11-07",
    "fda_recalls_as_of": "2026-11-01",
    "registry_facts_computed": "2026-11-14",
    "status_as_of": "2026-11-14",
    "license": "CC BY 4.0",
    "license_url": "https://creativecommons.org/licenses/by/4.0/",
    "license_scope": "The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.",
    "attribution": "DevicErts, https://devicerts.com/manufacturers/vortex-surgical-inc",
    "disclaimer": "Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails."
  },
  "manufacturer": {
    "name": "Vortex Surgical, Inc.",
    "url": "https://devicerts.com/manufacturers/vortex-surgical-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [
      "Vortex Surgical"
    ],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000022888"
      },
      {
        "label": "DUNS",
        "value": "080375891"
      }
    ],
    "summary": "Vortex Surgical, Inc. is a medical device manufacturer based in the United States, with 185 devices listed in FDA GUDID and EUDAMED (FDA Class I and II; EU Class IIa) and 15 FDA recalls as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 185,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 15,
    "fda_recalls_ongoing": 14,
    "fda_recalls_ongoing_recent": 14,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "Every device of the manufacturer. A device listed in two registries counts in both.",
    "registries": [
      {
        "registry": "FDA GUDID",
        "devices": 152
      },
      {
        "registry": "EUDAMED",
        "devices": 69
      }
    ],
    "device_classes": [
      {
        "class": "FDA Class I",
        "devices": 91
      },
      {
        "class": "EU Class IIa",
        "devices": 64
      },
      {
        "class": "FDA Class II",
        "devices": 30
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Q02",
        "name": "Ophthalmic devices",
        "url": "https://devicerts.com/categories/emdn/Q02",
        "devices": 64
      },
      {
        "code": "A01",
        "name": "Needles",
        "url": "https://devicerts.com/categories/emdn/A01",
        "devices": 1
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "Emergo Europe B.V.",
        "url": "https://devicerts.com/representatives/emergo-europe-bv-nl-ar-000000116",
        "country": "Netherlands"
      }
    ]
  },
  "devices": {
    "shown": 50,
    "total": 185,
    "all_devices_url": "https://devicerts.com/manufacturers/vortex-surgical-inc",
    "items": [
      {
        "name": "Tecfen Retractable Membrane Polisher 25G Box of 5",
        "url": "https://devicerts.com/devices/tecfen-retractable-membrane-polisher-25g-box-of-5-qtpr1267-25",
        "model_reference": "QTPR1267-25",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "23ga Embrace Elevator Box of 5",
        "url": "https://devicerts.com/devices/23ga-embrace-elevator-box-of-5-vs0370-23",
        "model_reference": "VS0370.23",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tecfen Retractable Membrane Polisher 23G Box of 5",
        "url": "https://devicerts.com/devices/tecfen-retractable-membrane-polisher-23g-box-of-5-qtpr1267-23",
        "model_reference": "QTPR1267-23",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tecfen Membrane Polisher 23G Box of 5",
        "url": "https://devicerts.com/devices/tecfen-membrane-polisher-23g-box-of-5-qtp1267-23",
        "model_reference": "QTP1267-23",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "27ga Intuitive Extendable MaxReach Laser Probe Box of 5",
        "url": "https://devicerts.com/devices/27ga-intuitive-extendable-maxreach-laser-probe-box-of-5-vs0142-27",
        "model_reference": "VS0142.27",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "23ga Intuitive Extendable MaxReach Laser Probe Box of 5",
        "url": "https://devicerts.com/devices/23ga-intuitive-extendable-maxreach-laser-probe-box-of-5-vs0142-23",
        "model_reference": "VS0142.23",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Tecfen Membrane Polisher 25G Box of 5",
        "url": "https://devicerts.com/devices/tecfen-membrane-polisher-25g-box-of-5-qtp1267-25",
        "model_reference": "QTP1267-25",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "25ga Intuitive Extendable MaxReach Laser Probe Box of 5",
        "url": "https://devicerts.com/devices/25ga-intuitive-extendable-maxreach-laser-probe-box-of-5-vs0142-25",
        "model_reference": "VS0142.25",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "25ga Embrace Elevator Box of 5",
        "url": "https://devicerts.com/devices/25ga-embrace-elevator-box-of-5-vs0370-25",
        "model_reference": "VS0370.25",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Versatile Soft Tip 23ga",
        "url": "https://devicerts.com/devices/versatile-soft-tip-vs0280-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Retractable ILM Elevator 23ga",
        "url": "https://devicerts.com/devices/retractable-ilm-elevator-vs0350-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "I² Kit for intraocular injection VS0510",
        "url": "https://devicerts.com/devices/i2-kit-for-intraocular-injection-vs0510",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "20ga Bending Laser Probe - Alcon Compatible VS0140.20A",
        "url": "https://devicerts.com/devices/20ga-bending-laser-probe-alcon-compatible-vs0140-20a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0640.25-XEX",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0640-25-xex",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0743.25",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0743-25",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0742.23",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0742-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0802",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0802",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0225C",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0225c",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "25ga Curved Laser Probe VS0120.25",
        "url": "https://devicerts.com/devices/25ga-curved-laser-probe-vs0120-25-adfaf8c9",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "TID - Todorich Illuminated Depressor VS0800",
        "url": "https://devicerts.com/devices/tid-todorich-illuminated-depressor-vs0800",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0644.25-FXX",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0644-25-fxx",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc. VS0803",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0803",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0740.23",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0740-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0202.27",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0202-27",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0350.25",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0350-25",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0640.25-FEX",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0640-25-fex",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0201.27",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0201-27",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "25ga Bending Laser Probe - Iridex Compatible VS0140.25I",
        "url": "https://devicerts.com/devices/25ga-bending-laser-probe-iridex-compatible-vs0140-25i",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "25ga Flexible Tapered Laser Probe - Alcon Compatible VS0130.25A",
        "url": "https://devicerts.com/devices/25ga-flexible-tapered-laser-probe-alcon-compatible-vs0130-25a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "23ga Bending Laser Probe - Alcon Compatible VS0140.23A",
        "url": "https://devicerts.com/devices/23ga-bending-laser-probe-alcon-compatible-vs0140-23a",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "27ga Straight Laser Probe VS0110.27",
        "url": "https://devicerts.com/devices/27ga-straight-laser-probe-vs0110-27-a1b82ed5",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0280.23",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0280-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0205.25B",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0205-25b",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0744.27-35",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0744-27-35",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0743.25-35",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0743-25-35",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0640.23-XEX",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0640-23-xex",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0205.25",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0205-25",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "27ga Soft Tip Cannula VS0200.27",
        "url": "https://devicerts.com/devices/27ga-soft-tip-cannula-vs0200-27",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "27ga Curved Laser Probe VS0120.27",
        "url": "https://devicerts.com/devices/27ga-curved-laser-probe-vs0120-27-20acd5f8",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "23ga Soft Tip Cannula VS0200.23",
        "url": "https://devicerts.com/devices/23ga-soft-tip-cannula-vs0200-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc. VS0753.27",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0753-27",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0800",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0800",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc. VS0125.25",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0125-25",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0520",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0520",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0350.23",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0350-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "EUDAMED",
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "25ga Flexible Tapered Laser Probe - Iridex Compatible VS0130.25I",
        "url": "https://devicerts.com/devices/25ga-flexible-tapered-laser-probe-iridex-compatible-vs0130-25i",
        "model_reference": null,
        "device_class": "Class II",
        "registries": [
          "GUDID"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0280.25",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0280-25",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0743.23",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0743-23",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0640.23-XXS",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0640-23-xxs",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vortex Surgical Inc VS0290",
        "url": "https://devicerts.com/devices/vortex-surgical-inc-vs0290",
        "model_reference": null,
        "device_class": "Class I",
        "registries": [
          "GUDID"
        ],
        "status": "Listed",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-1244-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HJK",
      "reason": "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."
    },
    {
      "number": "Z-1245-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HQB",
      "reason": "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."
    },
    {
      "number": "Z-1246-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HQB",
      "reason": "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."
    },
    {
      "number": "Z-1247-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HNR",
      "reason": "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."
    },
    {
      "number": "Z-1248-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "MXY",
      "reason": "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."
    },
    {
      "number": "Z-1249-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "KDD",
      "reason": "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."
    },
    {
      "number": "Z-1250-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "MXY",
      "reason": "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."
    },
    {
      "number": "Z-1251-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HNQ",
      "reason": "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."
    },
    {
      "number": "Z-1252-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "KDD",
      "reason": "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."
    },
    {
      "number": "Z-1253-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HNQ",
      "reason": "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."
    },
    {
      "number": "Z-1254-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HJM",
      "reason": "XXX"
    },
    {
      "number": "Z-1255-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "MXY",
      "reason": "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."
    },
    {
      "number": "Z-1256-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-12-16",
      "product_code": "HMQ",
      "reason": "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."
    },
    {
      "number": "Z-1004-2026",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2025-11-19",
      "product_code": "HQB",
      "reason": "Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly."
    },
    {
      "number": "Z-0970-2024",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2023-12-18",
      "product_code": "HNR",
      "reason": "Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots."
    }
  ]
}