{
  "format": "devicerts.manufacturer.v1",
  "cite_as": "Breg, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/breg-inc (data as of 2026-11-14).",
  "source": {
    "canonical_url": "https://devicerts.com/manufacturers/breg-inc",
    "json_url": "https://devicerts.com/manufacturers/breg-inc.json",
    "markdown_url": "https://devicerts.com/manufacturers/breg-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 registration and listing",
        "url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm"
      },
      {
        "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/breg-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": "Breg, Inc.",
    "url": "https://devicerts.com/manufacturers/breg-inc",
    "registered_as": null,
    "abbreviated_name": null,
    "also_registered_as": [],
    "country": "United States",
    "country_basis": "from SRN",
    "eudamed_status": {
      "status": "active",
      "since_year": null
    },
    "verified": false,
    "roles": [
      "Manufacturer"
    ],
    "registrations": [
      "EUDAMED",
      "FDA"
    ],
    "identifiers": [
      {
        "label": "EUDAMED SRN",
        "value": "US-MF-000018362"
      },
      {
        "label": "FDA FEI",
        "value": "3010694026"
      },
      {
        "label": "DUNS",
        "value": "604483321"
      }
    ],
    "summary": "Breg, Inc. is a medical device manufacturer based in the United States, with 4,628 devices listed and 15 FDA recalls as of 14 Nov 2026.",
    "noindex": false
  },
  "counts": {
    "devices": 4628,
    "devices_note": null,
    "certificates": 0,
    "fda_recalls_matched_by_name": 15,
    "fda_recalls_ongoing": 1,
    "fda_recalls_ongoing_recent": 1,
    "fda_recalls_ongoing_before": null,
    "fda_establishments": 0,
    "sites": 0
  },
  "registry_facts": {
    "covers": "The 3,000 best-ranked devices of 4,628.",
    "registries": [
      {
        "registry": "EUDAMED",
        "devices": 3000
      },
      {
        "registry": "FDA GUDID",
        "devices": 68
      }
    ],
    "device_classes": [
      {
        "class": "EU Class I",
        "devices": 2955
      },
      {
        "class": "FDA Class I",
        "devices": 42
      },
      {
        "class": "EU Class IIa",
        "devices": 2
      },
      {
        "class": "FDA Class II",
        "devices": 1
      }
    ],
    "top_emdn_categories": [
      {
        "code": "Y06",
        "name": "External prostheses and orthoses",
        "url": "https://devicerts.com/categories/emdn/Y06",
        "devices": 2932
      },
      {
        "code": "M90",
        "name": "Devices for general and specialist dressings - various",
        "url": "https://devicerts.com/categories/emdn/M90",
        "devices": 25
      }
    ]
  },
  "related": {
    "site_of": null,
    "part_of": null,
    "sites": [],
    "authorised_representatives": [
      {
        "name": "MDSS GmbH",
        "url": "https://devicerts.com/representatives/mdss-gmbh-de-ar-000005430",
        "country": "Germany"
      }
    ]
  },
  "devices": {
    "shown": 50,
    "total": 4628,
    "all_devices_url": "https://devicerts.com/manufacturers/breg-inc",
    "items": [
      {
        "name": "Polar Care Intl Power Supply, 6V",
        "url": "https://devicerts.com/devices/polar-care-intl-power-supply-6v-100316-000",
        "model_reference": "100316-000",
        "device_class": "Class IIa",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Calf Pad Kit Hi-At Duo Short Rt Xs",
        "url": "https://devicerts.com/devices/calf-pad-kit-hi-at-duo-short-rt-xs-ed030201",
        "model_reference": "ED030201",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Z12 Oa Cstm Al",
        "url": "https://devicerts.com/devices/z12-oa-cstm-al-az215000",
        "model_reference": "AZ215000",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CX2K Prefab Rt Xxl",
        "url": "https://devicerts.com/devices/cx2k-prefab-rt-xxl-22060",
        "model_reference": "22060",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Revolution 3 Lg Rc 24IN - 28IN",
        "url": "https://devicerts.com/devices/revolution-3-lg-rc-24in-28in-ek029005",
        "model_reference": "EK029005",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kit Sg Thrstr Leg Ath Ml/Lr L",
        "url": "https://devicerts.com/devices/kit-sg-thrstr-leg-ath-ml-lr-l-ta462107",
        "model_reference": "TA462107",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Calf Pad Kit Hi-Act Axe-D Rt 3XL",
        "url": "https://devicerts.com/devices/calf-pad-kit-hi-act-axe-d-rt-3xl-mg357213",
        "model_reference": "MG357213",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axiom Elite Athletic Rt S",
        "url": "https://devicerts.com/devices/axiom-elite-athletic-rt-s-pk429203",
        "model_reference": "PK429203",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duo Lat Comb Inst Athletic Short Rt S",
        "url": "https://devicerts.com/devices/duo-lat-comb-inst-athletic-short-rt-s-ed313203-ci",
        "model_reference": "ED313203-CI",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Select Knee Support, W/ Patella Cutout, Neoprene, M",
        "url": "https://devicerts.com/devices/select-knee-support-w-patella-cutout-neoprene-m-sa637005",
        "model_reference": "SA637005",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Boot Mid Calf J Walker Blk Xl",
        "url": "https://devicerts.com/devices/boot-mid-calf-j-walker-blk-xl-bl011009",
        "model_reference": "BL011009",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Thigh Strap Kit Z12/13 S",
        "url": "https://devicerts.com/devices/thigh-strap-kit-z12-13-s-az100003",
        "model_reference": "AZ100003",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CX2K Hp Prefab Rt Xxl",
        "url": "https://devicerts.com/devices/cx2k-hp-prefab-rt-xxl-24860",
        "model_reference": "24860",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Oa Imp Push Lat Tritech Rt Xl",
        "url": "https://devicerts.com/devices/oa-imp-push-lat-tritech-rt-xl-rk518209",
        "model_reference": "RK518209",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Econ Hinged Knee Am Ob S",
        "url": "https://devicerts.com/devices/econ-hinged-knee-am-ob-s-21712",
        "model_reference": "21712",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duo Medial Rt M",
        "url": "https://devicerts.com/devices/duo-medial-rt-m-ed112205-b",
        "model_reference": "ED112205--B",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Thigh Pad Kit Hi-At Duo Rt Xxl",
        "url": "https://devicerts.com/devices/thigh-pad-kit-hi-at-duo-rt-xxl-ed027211",
        "model_reference": "ED027211",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pfs Wrap L",
        "url": "https://devicerts.com/devices/pfs-wrap-l-11364",
        "model_reference": "11364",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Freestyle Plus Medial, Left Xs",
        "url": "https://devicerts.com/devices/freestyle-plus-medial-left-xs-kn1171-010",
        "model_reference": "KN1171-010",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Adjfit Mc Blk Xl",
        "url": "https://devicerts.com/devices/adjfit-mc-blk-xl-al056009",
        "model_reference": "AL056009",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lpr Prefab Rt S",
        "url": "https://devicerts.com/devices/lpr-prefab-rt-s-02220",
        "model_reference": "02220",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "WX2K Oa Prefab Rt M",
        "url": "https://devicerts.com/devices/wx2k-oa-prefab-rt-m-25630",
        "model_reference": "25630",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Z-13 Lt Xl",
        "url": "https://devicerts.com/devices/z-13-lt-xl-ez114109-b",
        "model_reference": "EZ114109--B",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Recover Knee Brace Neo Shrt M",
        "url": "https://devicerts.com/devices/recover-knee-brace-neo-shrt-m-00373",
        "model_reference": "00373",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axiom-D Elite Rt S",
        "url": "https://devicerts.com/devices/axiom-d-elite-rt-s-pk428203",
        "model_reference": "PK428203",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kit Sg Thrstr Leg Ath Ml/Lr Xl",
        "url": "https://devicerts.com/devices/kit-sg-thrstr-leg-ath-ml-lr-xl-ta462109",
        "model_reference": "TA462109",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Boot W/Bootie Lo Ez Set Blk Xl",
        "url": "https://devicerts.com/devices/boot-w-bootie-lo-ez-set-blk-xl-al070029bb",
        "model_reference": "AL070029BB-",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Calf Pad Kit Everyday Axe-D Lt S",
        "url": "https://devicerts.com/devices/calf-pad-kit-everyday-axe-d-lt-s-mg257103",
        "model_reference": "MG257103",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Kit Sg Duo Sht Ha Ath Mr/Ll Xs",
        "url": "https://devicerts.com/devices/kit-sg-duo-sht-ha-ath-mr-ll-xs-ed321201",
        "model_reference": "ED321201",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Calf Strap Kit Thrstr Rlf Xl",
        "url": "https://devicerts.com/devices/calf-strap-kit-thrstr-rlf-xl-ta010109",
        "model_reference": "TA010109",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Axiom Elite Ath Comb Instrt Xxl",
        "url": "https://devicerts.com/devices/axiom-elite-ath-comb-instrt-xxl-pk529211",
        "model_reference": "PK529211",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Softgait Walker Short Xs",
        "url": "https://devicerts.com/devices/softgait-walker-short-xs-100620-010",
        "model_reference": "100620-010",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pad Fus Lat Oa Plus C Rt M+",
        "url": "https://devicerts.com/devices/pad-fus-lat-oa-plus-c-rt-m-14335",
        "model_reference": "14335",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Sr Wa Ob M",
        "url": "https://devicerts.com/devices/sr-wa-ob-m-06803",
        "model_reference": "06803",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Pto Hp Airmesh Ob Rt M",
        "url": "https://devicerts.com/devices/pto-hp-airmesh-ob-rt-m-14303",
        "model_reference": "14303",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Thruster Lgcy Lat Short Gry Lt Xs",
        "url": "https://devicerts.com/devices/thruster-lgcy-lat-short-gry-lt-xs-ta418101",
        "model_reference": "TA418101",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Boot, Conformer, 1, Air, 14-15, Right",
        "url": "https://devicerts.com/devices/boot-conformer-1-air-14-15-right-al241214",
        "model_reference": "AL241214",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "CX2K Oa Prefab Rt L",
        "url": "https://devicerts.com/devices/cx2k-oa-prefab-rt-l-25440",
        "model_reference": "25440",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Calf Pad Kit Hi-Act Axe Rt Xxs",
        "url": "https://devicerts.com/devices/calf-pad-kit-hi-act-axe-rt-xxs-mg347200",
        "model_reference": "MG347200",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Z12 Adjustable Oa Med Lt Xxl",
        "url": "https://devicerts.com/devices/z12-adjustable-oa-med-lt-xxl-az294111-a",
        "model_reference": "AZ294111-A",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Softgait Air Walker M",
        "url": "https://devicerts.com/devices/softgait-air-walker-m-100617-030",
        "model_reference": "100617-030",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Calf Strap Kit Z12 D S",
        "url": "https://devicerts.com/devices/calf-strap-kit-z12-d-s-az108003",
        "model_reference": "AZ108003",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Calf Pad Kit Hi-Act Z13 Sport Lt M",
        "url": "https://devicerts.com/devices/calf-pad-kit-hi-act-z13-sport-lt-m-ez103105",
        "model_reference": "EZ103105",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Thruster Lgcy Med Std Gry Rt L",
        "url": "https://devicerts.com/devices/thruster-lgcy-med-std-gry-rt-l-ta409207",
        "model_reference": "TA409207",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Thigh Pad Kit Hi-Act Axe/Axe-D Rt 4XL",
        "url": "https://devicerts.com/devices/thigh-pad-kit-hi-act-axe-d-rt-4xl-mg346215",
        "model_reference": "MG346215",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Oa Imp Pull Med Tritech Lt Xxl",
        "url": "https://devicerts.com/devices/oa-imp-pull-med-tritech-lt-xxl-rk509111",
        "model_reference": "RK509111",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Lateral Pat Stab Neo 3D Rt S",
        "url": "https://devicerts.com/devices/lateral-pat-stab-neo-3d-rt-s-sa611203",
        "model_reference": "SA611203",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Vectr A Basic Air Tall, Xs",
        "url": "https://devicerts.com/devices/vectr-a-basic-air-tall-xs-97601",
        "model_reference": "97601",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Duo Lat Comb Inst Athletic Short Lt Xl",
        "url": "https://devicerts.com/devices/duo-lat-comb-inst-athletic-short-lt-xl-ed313109-ci",
        "model_reference": "ED313109-CI",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      },
      {
        "name": "Freerunner Rt L",
        "url": "https://devicerts.com/devices/freerunner-rt-l-100379-240",
        "model_reference": "100379-240",
        "device_class": "Class I",
        "registries": [
          "EUDAMED"
        ],
        "status": "Active",
        "decision_date": null,
        "open_recall": false
      }
    ]
  },
  "certificates": [],
  "recalls": [
    {
      "number": "Z-0231-2024",
      "classification": "Class II",
      "status": "Ongoing",
      "initiated": "2023-09-13",
      "product_code": "ITJ",
      "reason": "Due to walkers not meeting product specifications.  Walkers were manufactured with misaligned wheels."
    },
    {
      "number": "Z-1901-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1902-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1903-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1904-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1905-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1906-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1907-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1908-2017",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2017-03-30",
      "product_code": "KGX",
      "reason": "They may not have been sealed prior to sterilization.  Products with unsealed pouches will be non-sterile."
    },
    {
      "number": "Z-1446-2014",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2014-03-14",
      "product_code": "IQI",
      "reason": "Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because  they contain latex but were not labeled with the required caution label."
    },
    {
      "number": "Z-1447-2014",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2014-03-14",
      "product_code": "IQI",
      "reason": "Breg is recalling the Economy Elastic Knee Sleeve Open and K-Lite Knee 2 Stays with Visco because  they contain latex but were not labeled with the required caution label."
    },
    {
      "number": "Z-0803-2013",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2013-01-14",
      "product_code": "ILO",
      "reason": "The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance."
    },
    {
      "number": "Z-0804-2013",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2013-01-14",
      "product_code": "ILO",
      "reason": "The recall was initiated because Breg has determined that some Sterile Polar Pads products manufactured from January 2010 to October 2012 may have sustained damage to the product packaging which may compromise product sterility assurance."
    },
    {
      "number": "Z-2326-2012",
      "classification": "Class II",
      "status": "Terminated",
      "initiated": "2010-08-11",
      "product_code": "KGX",
      "reason": "This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg does not meet the required thickness as specified. The dressing in the sterile pouch measures a thickness of 0.010\" instead of 0.020\". This change in thickness makes the dressing\nthinner, less durable and subject to tearing. The product is mislabeled."
    },
    {
      "number": "Z-1989-2009",
      "classification": "Unclassified (pre-2012)",
      "status": "Terminated",
      "initiated": "2009-06-18",
      "product_code": "ILO",
      "reason": "Power supplies short-circuited at the electrical outlet upon initial use of the power supply, causing the circuit breaker for the electrical outlet to trip."
    }
  ]
}