Hollister, Inc.
Medical device manufacturer in Libertyville, IL.
100510(k) clearances
0PMA approvals
5recalls
Device types
- EXB Collector, Ostomy 14
- GBM Catheter, Urethral 11
- KPI Stimulator, Electrical, Non-Implantable… 10
- ILO Pack, Hot Or Cold, Water Circulating 7
- KNT Tubes, Gastrointestinal (And Accessories) 7
- FRO Dressing, Wound, Drug 6
- EZD Catheter, Straight 5
- FMQ Restraint, Protective 4
- HIR Perineometer 4
- KNX Collector, Urine, (And Accessories) For… 4
- FMZ Incubator, Neonatal 2
- KOZ Beads, Hydrophilic, For Wound Exudate… 2
- HDB Extractor, Vacuum, Fetal 2
- KOD Catheter, Urological 2
- EXI Device, Paste-On For Incontinence, Sterile 2
- HGY Pump, Breast, Non-Powered 2
- MGP Dressing, Wound And Burn, Occlusive 2
- EXJ Device, Incontinence, Urosheath Type, Sterile 2
- HFW Clamp, Umbilical 2
- NAD Dressing, Wound, Occlusive 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253295 | Coude Sleeved IC; Coude Plus Sleeved ICEZD · Traditional | 05/18/2026SE |
| K251468 | Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not…EZD · Traditional | 10/03/2025SE |
| K233524 | Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not…EZD · Traditional | 05/03/2024SE |
| K220667 | Sleeved ICEZD · Traditional | 12/08/2022SE |
| K213575 | Female IC (Not Finalized)EZD · Traditional | 09/13/2022SE |
| K211436 | Intermittent Catheter (Not Finalized)GBM · Traditional | 01/27/2022SE |
| K193148 | VaPro Plus Pocket, VaPro PlusGBM · Special | 12/13/2019SE |
| K191633 | Infyna ChicGBM · Special | 07/19/2019SE |
| K183253 | ValPro 2 Plus, VaPro 2 Plus PocketGBM · Special | 12/18/2018SE |
| K180824 | VaPro 2 Intermittent CatheterGBM · Special | 06/22/2018SE |
| K163179 | Onli Intermittent CatheterGBM · Special | 01/26/2017SE |
| K152268 | VAPRO PLUS POCKET Intermittent CatheterGBM · Special | 09/09/2015SE |
| K143594 | VaPro PocketGBM · Special | 01/09/2015SE |
| K141642 | Vapro Intermittent CatheterGBM · Special | 08/22/2014SE |
| K123804 | Instaflo Bowel Catheter System KitKNT · Traditional | 04/17/2013SE |
| K110862 | Vapro Plus Intermittent CatheterGBM · Special | 04/26/2011SE |
| K100273 | Instaflo Bowel Catheter System KitKNT · Special | 04/22/2010SESK |
| K090960 | Vapro Intermittent Catheter, Model 72062, 72082,72102, 72122, 72142, 72064, 72084…GBM · Traditional | 08/20/2009SE |
| K083153 | Actiflo Indwelling Bowel Catheter System Kit, Models: 32004, 32005, 32006, 32007KNT · Traditional | 02/04/2009SESK |
| K050483 | Evadri Bladder Control SystemsKPI · Traditional | 04/12/2005SE |
| K040779 | Restore Wound CleanserKMF · Traditional | 05/17/2004SE |
| K013612 | Incare Pelvic Floor Therapy SystemHIR · Traditional | 03/19/2002SE |
| K013653 | Incare Pressure Biofeedback Vaginal Pressure Probe and Anal Pressure ProbeHIR · Traditional | 03/05/2002SE |
| K013483 | Incare Advance; Intermittent Catheter, Plus Intermittent Catheter, Plus KitKOD · Traditional | 01/14/2002SE |
| K013345 | Incare Intermittent CatheterKOD · Traditional | 01/07/2002SE |
| K013141 | Microgyn Plus Stimulation DeviceKPI · Traditional | 12/19/2001SE |
| K011519 | Ameda HygienikitHGY · Traditional | 08/15/2001SE |
| K991214 | Simplicare Transparent Wound DressingMGP · Traditional | 10/14/1999SE |
| K990456 | Anal 2 Electrode Stimulation/Emg Probe - W/StopKPI · Traditional | 03/25/1999SE |
| K980976 | Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHDB · Traditional | 08/21/1998SE |
| K980209 | Simplicare Thin Film Wound DressingsMGP · Traditional | 02/20/1998SESK |
| K974048 | Incare Pelvic Floor Therapy System with Desktop ComputerKPI · Traditional | 12/23/1997SE |
| K973023 | Incare Hot/Ice System Foot/Ankle BlanketILO · Traditional | 11/03/1997SE |
| K971541 | Vaginal 2 Electrode Stimulation/Emg Probe - TamponKPI · Traditional | 06/25/1997SE |
| K970602 | Vaginal 2 Electrode Stimulation/Emg Probe-SmallKPI · Traditional | 04/15/1997SE |
| K970443 | Hollister Retracted Penis PouchEXI · Traditional | 02/25/1997SE |
| K964057 | Incare Hot/Ice System Shoulder BlanketILO · Traditional | 12/31/1996SE |
| K964006 | Incare Hot/Ice System Blankets (Various Sizes and Shapes)ILO · Traditional | 12/31/1996SE |
| K962537 | Incare Hot/Ice Lite MachineILO · Traditional | 11/27/1996SE |
| K963199 | Heelbo Pelvic RestraintFMQ · Traditional | 11/01/1996SE |
| K962964 | Heelbo Johnny Grait Belt Security BeltFMQ · Traditional | 10/24/1996SE |
| K962963 | Checkmate Ankle Restraint SystemFMQ · Traditional | 10/24/1996SE |
| K963222 | Microgyn Plus Stimulation DeviceKPI · Traditional | 10/23/1996SE |
| K963108 | Heelbo Quilted Torso RestraintFMQ · Traditional | 10/09/1996SE |
| K962900 | Self Retaining Male External Urinary CatheterEXJ · Traditional | 09/16/1996SE |
| K961872 | Incare Pelvic Floor Therapy System with Desktop ComputerKPI · Traditional | 08/09/1996SE |
| K960311 | PerineometerHIR · Traditional | 04/18/1996SE |
| K954621 | Reclosable Wound CoverFRO · Traditional | 10/23/1995SN |
| K930530 | Incare PRS 9300 Pelvic FL Thera Syst/Treat Uri IncKPI · Traditional | 10/17/1995SE |
| K954235 | Hollister Hydrocolloid Wound DressingFRO · Traditional | 10/06/1995SE |
| K950531 | Egnell EliteHGX · Traditional | 09/22/1995SE |
| K953232 | Hollister Nasogastric Tube Attachment DeviceKNT · Traditional | 08/18/1995SE |
| K950933 | Hollister Hydrocolloid Wound DressingsFRO · Traditional | 07/11/1995SE |
| K950176 | Premie U-Bag Urine Specimen CollectorFOC · Traditional | 02/07/1995SE |
| K944971 | Incare Hot/Ice Cold Therapy CoolerILO · Traditional | 01/30/1995SN |
| K940269 | Hollister Non-Rolled Self-Adhesive Urinary External CatheterEXJ · Traditional | 06/02/1994SE |
| K941858 | Gel CushionKIC · Traditional | 05/05/1994SE |
| K931843 | Hot/Ice System Sterile Conformable/Disp. BlanketsILO · Traditional | 02/02/1994SE |
| K912355 | Mothers Touch One Hand Breast PumpHGY · Traditional | 12/10/1993SE |
| K932855 | Hollister Vertical Drain/Tube Attachment DeviceKNT · Traditional | 10/13/1993SE |
| K931277 | Hollister Premium Urine CollectorEXI · Traditional | 06/23/1993SE |
| K926570 | Hollister(R) Bedside Drainage Collection Syst 9878KNX · Traditional | 05/21/1993SE |
| K922739 | Hollister Horizontal Drain/Tube Attachment DeviceGBX · Traditional | 08/06/1992SE |
| K915196 | Incare Hot/Ice System 3ILO · Traditional | 02/03/1992SE |
| K913035 | Incare Hot/Ice Absorbent InterfaceFRO · Traditional | 09/25/1991SE |
| K905206 | Incare Pinsite DressingKOZ · Traditional | 04/12/1991SE |
| K902056 | Laser Trap 100 Laser Plume Smoke Evacuation FilterJDY · Traditional | 10/30/1990SE |
| K901954 | Ameda/Egnell Dolphin Umbilical Cord Severing DevicHFW · Traditional | 07/26/1990SE |
| K895700 | Ameda/Egnell Dolphin Dispo-Soft Vacuum ExtractorHDB · Traditional | 04/02/1990SE |
| K893888 | Hollister Feeding Tube Attachment DeviceKNT · Traditional | 10/17/1989SE |
| K891774 | Contimed II Biofeedback Dev Treat of Urin IncontiHIR · Traditional | 08/23/1989SE |
| K891773 | Microgyn II Elec Stim Device Treat of Urin IncontiKPI · Traditional | 08/23/1989SE |
| K881678 | Self Adhesive Urinary External Cath. W/Remove. TipKNX · Traditional | 08/11/1988SE |
| K881039 | Hydrocolloid Dressing for PsoriasisFRO · Traditional | 06/22/1988SE |
| K870223 | Ameda Amelette(R) Neonatal IncubatorFMZ · Traditional | 06/10/1987SE |
| K870222 | Ameda Amecare(R) Neonatal IncubatorFMZ · Traditional | 06/10/1987SE |
| K862573 | Hollister Drain Tube AttachmentKNT · Traditional | 09/23/1986SE |
| K862934 | Hollister Female Urinary Collection PouchKNX · Traditional | 08/19/1986SE |
| K862572 | Hollister Wound Care BarrierFRO · Traditional | 08/04/1986SN |
| K822080 | Adhesive Wound Cover FilmNAD · Traditional | 10/15/1982SE |
| K821680 | Hollister Catheter Access. PortEXB · Traditional | 06/24/1982SE |
| K820160 | Hollister Wound Exudate AbsorberKOZ · Traditional | 04/21/1982SE |
| K820464 | Hollister Odor Absorbing Wound PadNAB · Traditional | 03/23/1982SE |
| K820234 | Hollister Female Urinary Collect SysKNX · Traditional | 02/10/1982SE |
| K813270 | Fecal Incontinence CollatorEXB · Traditional | 12/14/1981SE |
| K813269 | Two Piece Ostomy SystemEXB · Traditional | 12/03/1981SE |
| K810807 | Holliseal Ostomy Skin BarrierEXB · Traditional | 04/07/1981SE |
| K810710 | Hollister Skin Barrier BEXB · Traditional | 04/07/1981SE |
| K810709 | Hollister Skin Barrier aEXB · Traditional | 04/07/1981SE |
| K810708 | Hollister Male Urinary Incont. System · Traditional | 03/17/1981SESP |
| K801503 | Hollister Karaya Seal RingEXB · Traditional | 08/13/1980SE |
| K801504 | Hollister Drainage PouchFON · Traditional | 08/12/1980SE |
| K791535 | Hollister Stoma Pouch with Micro AdhesEXB · Traditional | 10/26/1979SE |
| K791526 | Hollister Stoma Pouch Skin BarrierEXB · Traditional | 10/26/1979SE |
| K791525 | Hollister Karaya PasteEXB · Traditional | 10/26/1979SE |
| K791534 | Hollister Urostomy PouchEXB · Traditional | 10/09/1979SE |
| K781548 | Umbilical Cord ClampHFW · Traditional | 10/17/1978SE |
| K781373 | Ostomy Appliance W/Deodorizing FilterEXB · Traditional | 09/20/1978SE |
| K770439 | Stoma Bag W/Skin Barrier Seal RingEXB · Traditional | 04/15/1977SE |
| K770178 | Stoma Bags W/Microporous AdhesiveEXB · Traditional | 02/01/1977SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1181-2025 Class II | AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 12/23/2024Open, Classified |
| Z-1180-2025 Class II | AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 12/23/2024Open, Classified |
| Z-1179-2025 Class II | AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,Hollister received reports of decreased skin barrier wear time which could can lead to tube migration | 12/23/2024Open, Classified |
| Z-1178-2025 Class II | 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 | 12/23/2024Open, Classified |
| Z-1311-2021 Class II | Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) -…The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder… | 02/11/2021Terminated |