New Image 11203Recalls & reported problems
Hollister Incorporated · 2-Piece Ostomy Skin Barrier, CeraPlus · Class 1
All models of New Image (19)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00610075029846), received between Jul 3, 2024 and Aug 19, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fluid/Blood Leak1
Patient problems
- Caustic/Chemical Burns1
- Skin Erosion1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryAug 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN END USER WHO HAD BEEN USING THE HOLLISTER NEW IMAGE CERAPLUS BARRIER DEVELOPED A WOUND ABOVE THE STOMA UNDER THE BARRIER AND THE AREA NOW NEEDS TO BE PACKED. IT WAS FURTHER REPORTED THAT THE WOUND HAD BEEN THERE FOR 5 WEEKS, AND SHE WENT TO A NURSE PRACTITIONER AT THE WOUND AND OSTOMY CLINIC. ADDITIONALLY, IT WAS REPORTED THAT THEY PRESCRIBED AND ORDERED THE WOUND PACKING SUPPLIES AND THAT THE WOUND IS BEING TENDED TO BY A HOME HEALTH NURSE. HOLLISTER IS SENDING OUT A DIFFERENT OSTOMY PRODUCT FOR HER TO TRIAL.
Patient problems: Skin Erosion
MAUDE report 22840785 ↗InjuryJul 3, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE END USER HAS BEEN RECEIVING CHEMO FOR THE LAST 4 YEARS. IT WAS REPORTED THAT DURING THIS WHOLE TIME, URINE HAS BEEN LEAKING UNDER THE UROSTOMY BARRIER AND BURNING HIS SKIN FROM THE CHEMOTHERAPY IN THE URINE. IT WAS REPORTED THAT THE SKIN LOOKS LIKE A 3RD DEGREE BURN, IRRITATED, AND WAS NOT GETTING ANY BETTER. IT WAS FURTHER REPORTED THAT THE DOCTOR PRESCRIBED ORAL PREDNISONE 3 DAYS AGO FOR A 5-DAY TAPERING SCHEDULE. IT WAS REPORTED THAT THE SKIN IS ALREADY FEELING BETTER. HOLLISTER IS SENDING OUT SAMPLES OF OTHER PRODUCTS TO TRY.
Patient problems: Caustic/Chemical Burns; Skin Inflammation/ Irritation
MAUDE report 19665720 ↗
Other COLLECTOR, OSTOMY devices
- New Image 11704Hollister Incorporated · COLLECTOR, OSTOMY4 reports
- New Image 14803Hollister Incorporated · COLLECTOR, OSTOMY3 reports
- New Image 11504Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 14603Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- New Image 11703Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8331Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8512Hollister Incorporated · COLLECTOR, OSTOMY1 report
- Premier 88400Hollister Incorporated · COLLECTOR, OSTOMY1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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