Hollister Incorporated
Stuarts Draft, VA, US
HOLLISTER INCORPORATED appears in FDA device records in Stuarts Draft, VA. FDA records list 15 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Hollister Incorporated between 2011 and 2026. The busiest year on record is 2022, with 3. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2017 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2022 | 3 |
| 2024 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253295 | Coude Sleeved IC; Coude Plus Sleeved IC | EZD | Substantially Equivalent | |
| K251468 | 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) | EZD | Substantially Equivalent | |
| K233524 | 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) | EZD | Substantially Equivalent | |
| K220667 | Sleeved IC | EZD | Substantially Equivalent | |
| K213575 | Female IC (Not Finalized) | EZD | Substantially Equivalent | |
| K211436 | Intermittent Catheter (Not Finalized) | GBM | Substantially Equivalent | |
| K193148 | VaPro Plus Pocket, VaPro Plus | GBM | Substantially Equivalent | |
| K191633 | Infyna Chic | GBM | Substantially Equivalent | |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | GBM | Substantially Equivalent | |
| K180824 | VaPro 2 Intermittent Catheter | GBM | Substantially Equivalent | |
| K163179 | Onli Intermittent Catheter | GBM | Substantially Equivalent | |
| K152268 | VAPRO PLUS POCKET Intermittent Catheter | GBM | Substantially Equivalent | |
| K143594 | VaPro Pocket | GBM | Substantially Equivalent | |
| K141642 | VAPRO INTERMITTENT CATHETER | GBM | Substantially Equivalent | |
| K110862 | VAPRO PLUS INTERMITTENT CATHETER | GBM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1119193 | 1119193 | HOLLISTER INCORPORATED | 366 Draft Ave, STUARTS DRAFT, VA 24477 US | 2026 | and 2 more, listed in full below |
| 1480288 | 1480288 | HOLLISTER INCORPORATED | 2000 HOLLISTER DR., LIBERTYVILLE, IL 60048 US | 2026 | and 21 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- EZSAppliance, Colostomy, Disposable
- GDSBag, Stomal
- EXGBag, Urine Collecting, Ureterostomy
- NNWBag, Urine Collection, Leg, For External Use, Non-Sterile
- FAQBag, Urine Collection, Leg, For External Use, Sterile
- KMFBandage, Liquid
- NECBandage, Liquid, Skin Protectant
- FOBBedpan
- OHRCatheter Care Tray
- GBXCatheter, Irrigation
- EZDCatheter, Straight
- GBMCatheter, Urethral
- KODCatheter, Urological
- EZRCement, Stomal Appliance, Ostomy
- EXBCollector, Ostomy
- CBHDevice, Fixation, Tracheal Tube
- NNXDevice, Incontinence, Urosheath Type, Non-Sterile
- NOADevice, Paste-On For Incontinence, Non-Sterile
- FRODressing, Wound, Drug
- NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic
- NADDressing, Wound, Occlusive
- FCEEnema Kit
- EXDIrrigator, Ostomy
- PQEOstomy Care Kit
- EXEProtector, Ostomy
- EZPRod, Colostomy
- KOXSolvent, Adhesive Tape
- NNZSystem, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
- EYZSystem, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
- FCMTray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
- KNTTubes, Gastrointestinal (And Accessories)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1181-2025 | AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Class II | Open, Classified | |
| Z-1180-2025 | AnchorFast, Oral Endotracheal Tube Fastener, REF 9799, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Class II | Open, Classified | |
| Z-1179-2025 | AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Class II | Open, Classified | |
| Z-1178-2025 | AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700, | Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | Class II | Open, Classified | |
| Z-1311-2021 | Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-40 French. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain