{
  "companyId": "50982",
  "slug": "hollister-incorporated-50982",
  "name": "Hollister Incorporated",
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    "total": 100,
    "last12Months": 2,
    "first": "1977-02-01",
    "latest": "2026-05-18"
  },
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  "productCodeCount": 28,
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    "total": 5,
    "openLast12Months": 0,
    "recent": [
      {
        "resNumber": "Z-1178-2025",
        "productCode": "CBH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-12-23",
        "reason": "Hollister received reports of decreased skin barrier wear time which could can lead to tube migration"
      },
      {
        "resNumber": "Z-1179-2025",
        "productCode": "CBH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-12-23",
        "reason": "Hollister received reports of decreased skin barrier wear time which could can lead to tube migration"
      },
      {
        "resNumber": "Z-1180-2025",
        "productCode": "CBH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-12-23",
        "reason": "Hollister received reports of decreased skin barrier wear time which could can lead to tube migration"
      },
      {
        "resNumber": "Z-1181-2025",
        "productCode": "CBH",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "initiated": "2024-12-23",
        "reason": "Hollister received reports of decreased skin barrier wear time which could can lead to tube migration"
      },
      {
        "resNumber": "Z-1311-2021",
        "productCode": "KNT",
        "status": "Terminated",
        "recallClass": "Class II",
        "initiated": "2021-02-11",
        "reason": "The tube holder can separate from the barrier that secures the device to the patients' body.  The tube holder has the potential failure to separate from the barrier. This separation might contribute to the potential risk of the tube/drain/catheter migration or loss."
      }
    ]
  },
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    "sites": 3,
    "countries": [
      "US"
    ]
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    {
      "code": "EXB",
      "deviceName": "Collector, Ostomy",
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      "medianReviewDays": 24
    },
    {
      "code": "GBM",
      "deviceName": "Catheter, Urethral",
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      "latest": "2022-01-27",
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    },
    {
      "code": "KPI",
      "deviceName": "Stimulator, Electrical, Non-Implantable, For Incontinence",
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      "latest": "2005-04-12",
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    },
    {
      "code": "ILO",
      "deviceName": "Pack, Hot Or Cold, Water Circulating",
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      "latest": "1997-11-03",
      "medianReviewDays": 85
    },
    {
      "code": "KNT",
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      "latest": "2013-04-17",
      "medianReviewDays": 103
    },
    {
      "code": "FRO",
      "deviceName": "Dressing, Wound, Drug",
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      "latest": "1995-10-23",
      "medianReviewDays": 28
    },
    {
      "code": "EZD",
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      "latest": "2026-05-18",
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    },
    {
      "code": "FMQ",
      "deviceName": "Restraint, Protective",
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      "latest": "1996-11-01",
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    },
    {
      "code": "HIR",
      "deviceName": "Perineometer",
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      "latest": "2002-03-19",
      "medianReviewDays": 119
    },
    {
      "code": "KNX",
      "deviceName": "Collector, Urine, (And Accessories) For Indwelling Catheter",
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      "latest": "1993-05-21",
      "medianReviewDays": 15
    },
    {
      "code": "EXI",
      "deviceName": "Device, Paste-On For Incontinence, Sterile",
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      "latest": "1997-02-25",
      "medianReviewDays": 20
    },
    {
      "code": "EXJ",
      "deviceName": "Device, Incontinence, Urosheath Type, Sterile",
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      "latest": "1996-09-16",
      "medianReviewDays": 53
    },
    {
      "code": "FMZ",
      "deviceName": "Incubator, Neonatal",
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      "latest": "1987-06-10",
      "medianReviewDays": 140
    },
    {
      "code": "HDB",
      "deviceName": "Extractor, Vacuum, Fetal",
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      "latest": "1998-08-21",
      "medianReviewDays": 158
    },
    {
      "code": "HFW",
      "deviceName": "Clamp, Umbilical",
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      "latest": "1990-07-26",
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    },
    {
      "code": "HGY",
      "deviceName": "Pump, Breast, Non-Powered",
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      "medianReviewDays": 90
    },
    {
      "code": "KOD",
      "deviceName": "Catheter, Urological",
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      "latest": "2002-01-14",
      "medianReviewDays": 87
    },
    {
      "code": "KOZ",
      "deviceName": "Beads, Hydrophilic, For Wound Exudate Absorption",
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      "latest": "1991-04-12",
      "medianReviewDays": 91
    },
    {
      "code": "MGP",
      "deviceName": "Dressing, Wound And Burn, Occlusive",
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      "latest": "1999-10-14",
      "medianReviewDays": 31
    },
    {
      "code": "FOC",
      "deviceName": "Bag, Urine Collection, Newborn",
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      "latest": "1995-02-07",
      "medianReviewDays": 21
    },
    {
      "code": "FON",
      "deviceName": "Bag, Drainage, With Adhesive, Ostomy",
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      "latest": "1980-08-12",
      "medianReviewDays": 46
    },
    {
      "code": "GBX",
      "deviceName": "Catheter, Irrigation",
      "clearances": 1,
      "latest": "1992-08-06",
      "medianReviewDays": 59
    },
    {
      "code": "HGX",
      "deviceName": "Pump, Breast, Powered",
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    },
    {
      "code": "JDY",
      "deviceName": "Evacuator, Vapor, Cement Monomer",
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      "latest": "1990-10-30",
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    },
    {
      "code": "KIC",
      "deviceName": "Cushion, Flotation",
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      "latest": "1994-05-05",
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  "productCodesTotal": "28",
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      "kNumber": "K253295",
      "deviceName": "Coude Sleeved IC; Coude Plus Sleeved IC",
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    },
    {
      "kNumber": "K251468",
      "deviceName": "Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A)",
      "productCode": "EZD",
      "decisionDate": "2025-10-03",
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    {
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      "deviceName": "Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)",
      "productCode": "EZD",
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    },
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    },
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    },
    {
      "kNumber": "K191633",
      "deviceName": "Infyna Chic",
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    {
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    {
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      "decisionDate": "2018-06-22",
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    "shown": [
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        "name": "HOLLISTER INCORPORATED",
        "dataset": "device/registrationlisting",
        "method": "normalised"
      },
      {
        "name": "HOLLISTER, INC.",
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        "method": "normalised"
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      {
        "name": "Hollister Incorporated",
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        "method": "normalised"
      },
      {
        "name": "Hollister Incorporated",
        "dataset": "device/enforcement",
        "method": "normalised"
      },
      {
        "name": "Hollister Incorporated",
        "dataset": "device/510k",
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        "name": "Hollister, Inc.",
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        "method": "normalised"
      }
    ]
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  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Hollister%20Incorporated%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Hollister%20Incorporated%22"
  },
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      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
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  "retrievedAt": "2026-08-11T14:48:53.045Z"
}