New Image 11204Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00610075029853), received between Feb 17, 2026 and Feb 17, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
Patient problems
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 17, 2026Leak/Splash
IT WAS REPORTED THAT AN END USER HAD BEEN USING SEVERAL HOLLISTER OSTOMY BARRIERS A DAY AFTER SHE LOST 60 POUNDS AND THERE WAS A LOT OF LOOSE SKIN. IT WAS FURTHER REPORTED THAT SHE WAS EXPERIENCING BARRIER LEAKAGE ON THE BOTTOM OR LEFT SIDE AND HAD IRRITATION WITH FUNGAL AND YEAST INFECTIONS. IT WAS ADDITIONALLY REPORTED THAT SHE HAS BEEN USING PREDNISONE CREAM PER HER DOCTOR WHICH IS NOT ALLOWING HER BARRIER TO ADHERE TO THE SKIN. HOLLISTER PROVIDED SUGGESTIONS TO END USER.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 24367071 ↗
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
- New Image 11203Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8331Hollister Incorporated · COLLECTOR, OSTOMY2 reports
- Premier 8512Hollister 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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