New Image 11704Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00610075069095), received between Oct 15, 2025 and Aug 14, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Cellulitis

  MAUDE report 50251750 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN OSTOMATE EXPERIENCED SKIN IRRITATION, REDNESS AND OOZING UNDER THE BARRIER AFTER USING THREE DIFFERENT HOLLISTER PRODUCTS FOR A PERIOD OF TIME. THIS IS THE FIRST OF THE 3 PRODUCTS, 11704 HOLLISTER NEW IMAGE BARRIER. IT WAS REPORTED THAT THE PATIENT TRIED USING OTHER OSTOMY PRODUCTS AND THE IRRITATION BECAME WORSE. THE PATIENT REPORTED EVENTUALLY EXPERIENCING EXTREME ITCHINESS ON HIS ARMS, LEGS, CHEST AND BACK, WITH LITTLE BUMPS. THE PATIENT ALSO REPORTED HE WENT TO THE WOUND CARE NURSE AND WAS PRESCRIBED TRIAMCINOLONE CREAM AND A DIFFERENT BARRIER PRODUCT. IT WAS FURTHER REPORTED THAT THE REACTION CONTINUED AND THEN HE DEVELOPED A GENERALIZED REACTION WITH HIVES AND ITCHING OVER MOST OF HIS BODY. THE PATIENT REPORTED HE WENT TO THE URGENT CARE CENTER AND RECEIVED A STEROID SHOT AND A STEROID DOSE PACK AFTER WHICH HE FELT BETTER. HOLLISTER HAS ADVISED THE PATIENT TO SEEK ATTENTION FROM HIS HEALTH CARE PROFESSIONALS BEFORE USING THE HOLLISTER BARRIER AGAIN.

  Patient problems: Erythema; Rash; Skin Inflammation/ Irritation; Urticaria

  MAUDE report 24891390 ↗
• InjuryFeb 9, 2026Patient Device Interaction Problem

  IT WAS REPORTED THAT AN END USER DEVELOPED IRRITATION WITH WEEPING AND BLISTERS UNDER THE TAPE BORDER OF THE HOLLISTER OSTOMY BARRIER 5 MONTHS AFTER HE FIRST STARTED USING THE PRODUCT. IT WAS FURTHER REPORTED THAT DESPITE USING STOMA POWDER AND SKIN PREP, THE IRRITATION CONTINUED. IT WAS REPORTED HE WENT TO SEE HIS HEALTH CARE PROFESSIONAL WHO PRESCRIBED CLOBETASOL CREAM TO BE USED TWICE A WEEK AND THE AREA IS NOW IMPROVING.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24293140 ↗
• InjuryOct 15, 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 PREVIOUSLY USED A SKIN PROTECTANT WIPE BENEATH A HOLLISTER CONVEX OSTOMY BARRIER WAS TRAILING A HOLLISTER SOFT CONVEX CERAPLUS BARRIER WITHOUT THE SKIN PROTECTANT, DURING WHICH BLISTERS FORMED UNDER THE TAPE BORDER. IT WAS FURTHER REPORTED THAT THE BLISTERS RUPTURED, PROMPTING A VISIT TO AN URGENT CARE FACILITY WHERE A MEDICAL PROFESSIONAL PRESCRIBED A TOPICAL ANTIBIOTIC OINTMENT FOR THE BROKEN SKIN AND PROVIDED SAMPLES OF A STEROID TOPICAL TREATMENT FOR ADJACENT ERYTHEMATOUS, NON-BROKEN SKIN. IT WAS SUBSEQUENTLY REPORTED THAT THE AREA IS HEALING, AND THE USER HAS RESUMED USE OF THE ORIGINAL HOLLISTER CONVEX OSTOMY BARRIER ALONG WITH THE SKIN PROTECTANT WIPES.

  Patient problems: Blister; Erythema

  MAUDE report 23293373 ↗