Hollister 8900Recalls & reported problems
Hollister Incorporated · CeraPlus Skin Barrier · Class 1
Data updated Oct 18, 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 00610075087518), received between Jul 24, 2025 and Jul 24, 2025 — classified as 1 injury.
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Rash1
- Skin Discoloration1
- Skin Infection1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN END USER OF THE HOLLISTER CERAPLUS SKIN BARRIER, APPLIED BENEATH THE HOLLISTER OSTOMY APPLIANCE, EXPERIENCED AREAS OF DISCOLORED SKIN ACCOMPANIED BY A RASH RESEMBLING MEASLES, WHICH WERE DESCRIBED AS STINGING AND PRICKLY, AND APPEARED SPORADICALLY UNDER THE SKIN BARRIER. IT WAS ALSO REPORTED THAT THE END USER SAW A DERMATOLOGIST, WHO DIAGNOSED THE CONDITION AS A FUNGAL INFECTION AND PRESCRIBED NYSTATIN POWDER. IN ADDITION, IT WAS REPORTED THAT THE END USER WILL TRY A DIFFERENT OSTOMY APPLIANCE, CHANGE THEIR SKIN PREPARATION ROUTINE, AND FOLLOW UP WITH THE DERMATOLOGIST.
Patient problems: Rash; Skin Discoloration; Skin Infection
MAUDE report 22591458 ↗
Other PROTECTOR, OSTOMY devices
- NATURA 404593Convatec, Purchasing Department · PROTECTOR, OSTOMY2,403 reports
- SUR-FIT NATURA 413182Convatec, Purchasing Department · PROTECTOR, OSTOMY1,202 reports
- SUR-FIT NATURA 413180Convatec, Purchasing Department · PROTECTOR, OSTOMY1,190 reports
- SUR-FIT NATURA 413179Convatec, Purchasing Department · PROTECTOR, OSTOMY1,178 reports
- SUR-FIT NATURA 413181Convatec, Purchasing Department · PROTECTOR, OSTOMY974 reports
- NATURA 411802Convatec, Purchasing Department · PROTECTOR, OSTOMY966 reports
- NATURA 404592Convatec, Purchasing Department · PROTECTOR, OSTOMY907 reports
- SUR-FIT NATURA 413183Convatec, Purchasing Department · PROTECTOR, OSTOMY773 reports
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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