New ImageRecalls & reported problems across all models

We found 19 models of New Image by Hollister Incorporated in the FDA's device registry (GUDID). Together they are named in 28 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2022 and Aug 26, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported New Image problems

New Image models

19 models, most reported first. Each model has its own page with its reports, recalls and device details.

• New Image 11704

  COLLECTOR, OSTOMY
  4 reports
• New Image 14803

  COLLECTOR, OSTOMY
  3 reports
• New Image 11203

  COLLECTOR, OSTOMY
  2 reports
• New Image 11504

  COLLECTOR, OSTOMY
  2 reports
• New Image 11703

  COLLECTOR, OSTOMY
  2 reports
• New Image 14603

  COLLECTOR, OSTOMY
  2 reports
• New Image 11204

  COLLECTOR, OSTOMY
  1 report
• New Image 15303

  COLLECTOR, OSTOMY
  1 report
• New Image 11702

  COLLECTOR, OSTOMY
  1 report
• New Image 14703

  COLLECTOR, OSTOMY
  1 report
• New Image 16103

  COLLECTOR, OSTOMY
  1 report
• New Image 16104

  COLLECTOR, OSTOMY
  1 report
• New Image 18003

  COLLECTOR, OSTOMY
  1 report
• New Image 18004

  COLLECTOR, OSTOMY
  1 report
• New Image 18373

  COLLECTOR, OSTOMY
  1 report
• New Image 14908

  COLLECTOR, OSTOMY
  1 report
• New Image 14602

  COLLECTOR, OSTOMY
  1 report
• New Image 14904

  COLLECTOR, OSTOMY
  1 report
• New Image 15603

  COLLECTOR, OSTOMY
  1 report

Recent New Image adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the user experienced skin irritation associated with use of Hollister New Image 2-Piece Drainable Ostomy Pouch. It was reported that the fabric material of product 18004 was perceived to be heavier, rubbed against the skin, caused redness in areas of contact, and was more difficult to empty. It was also reported that the user began wearing undergarments and using a belt to reduce contact between the pouch and the skin. It was reported that the user had a large hernia, a prolapsed stoma, and an increase in stoma size. It was reported that the user had been evaluated by a nurse and physician and was being treated with prescribed Nystatin powder for a suspected yeast-related skin condition; however, the treatment reportedly did not improve the symptoms. It was also reported that the nurse believed the condition to be dermatitis. It was reported that the symptoms remained ongoing at the time of the report. It was also reported that medical intervention was required, including evaluation by healthcare professionals and treatment with prescribed Nystatin powder.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 50451162 ↗
• 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 24, 2026Leak/Splash

  IT WAS REPORTED THAT AN END USER'S HOLLISTER NEW IMAGE BARRIER WAS ONLY ADHERING 1-3 DAYS LEADING TO LEAKAGE, SKIN IRRITATION AND PAIN. IT WAS REPORTED HE WENT TO THE HOSPITAL FOR THE RASH AND PAIN, AND THEY PRESCRIBED A 5-DAY COURSE OF HIGH DOSE IBUPROFEN. IT WAS FURTHER REPORTED THAT OVER TIME, THE WEAR TIME AND SKIN IRRITATION HAS NOT IMPROVED AND SO NOW HE IS ON AN ANTIBIOTIC OINTMENT FOR THE SKIN.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24429570 ↗
• 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 ↗
• 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 ↗
• InjuryJan 8, 2026Leak/Splash

  IT WAS REPORTED THAT THE LAST TWO BOXES OF HOLLISTER COLOSTOMY POUCHES THAT THE END USER RECEIVED HAD POUCHES THAT WERE OPEN AS IF THEY WERE "CUT WITH A RAZOR BLADE". IT WAS FURTHER REPORTED THAT THE OUTPUT LEAKED ALL OVER THE END USER AND THAT HE EXPERIENCED MULTIPLE BLADDER INFECTIONS FROM IT. ADDITIONALLY, IT WAS REPORTED THAT THE END USER WAS SICK AND HOSPITALIZED FOR THE BLADDER INFECTIONS. DESPITE MULTIPLE ATTEMPTS, HOLLISTER WAS UNABLE TO OBTAIN FURTHER EVENT INFORMATION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24009603 ↗
• InjuryOct 23, 2025Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED THAT AN END USER EXPERIENCED EFFLUENT LEAKAGE WHEN THE LOCK N ROLL CLOSURE OF THE HOLLISTER NEW IMAGE DRAINABLE POUCH UNROLLED. IT WAS REPORTED THAT THE END USER WEARS DEPENDS, WHICH ALSO COVERS THE POUCH, AND THE POUCH HAS BEEN OPENING, RESULTING IN CONTENTS LEAKING OUT INTO THE DEPENDS. IT WAS FURTHER REPORTED THAT THE LEAKAGE INTO HER DEPENDS ON LED TO A URINARY TRACT INFECTION (UTI), FOR WHICH SHE REQUIRED ANTIBIOTIC TREATMENT.

  Patient problems: Urinary Tract Infection

  MAUDE report 23366856 ↗
• InjuryOct 23, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT AN END USER EXPERIENCED EFFLUENT LEAKAGE WHEN THE EDGES OF THE HOLLISTER NEW IMAGE BARRIER CURLED UP. IT WAS REPORTED THAT THE END USER WEARS DEPENDS, WHICH ALSO COVERS THE BARRIER, AND THE BARRIER EDGES HAVE BEEN CURLING UP, RESULTING IN STOMA CONTENTS LEAKING OUT INTO THE DEPENDS. IT WAS FURTHER REPORTED THAT THE LEAKAGE INTO HER DEPENDS LED TO A URINARY TRACT INFECTION (UTI), FOR WHICH SHE REQUIRED ANTIBIOTIC TREATMENT.

  Patient problems: Urinary Tract Infection

  MAUDE report 23366225 ↗
• 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 ↗
• 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 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN END USER DEVELOPED A RASH BENEATH THE HOLLISTER NEW IMAGE BARRIER. THE AFFECTED SKIN APPEARED RED AND MAY HAVE INCLUDED BLISTERING. IT WAS REPORTED THAT SORES WERE ALSO PRESENT AROUND THE OUTER EDGE OF THE BARRIER. THESE SORES HAVE PERSISTED FOR APPROXIMATELY 4-5 WEEKS, BEGINNING AS A SINGLE SORE THAT DID NOT RESOLVE. IT WAS FURTHER REPORTED THAT THE AREA SURROUNDING THE STOMA WAS MILDLY AFFECTED, DESCRIBED AS PINKISH IN APPEARANCE. ADDITIONALLY, IT WAS REPORTED THAT THE END USER SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED A TOPICAL CREAM: TRIAMCINOLONE ACETONIDE USP 0.1%.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 22803489 ↗
• InjuryMay 2, 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 OSTOMY BARRIER FOR OVER THREE YEARS STARTED EXPERIENCING SKIN INFLAMMATION AND REDNESS UNDER THE BARRIER OVER THE LAST MONTH. IT WAS FURTHER REPORTED THAT THE END USER TRIED STEROID SPRAY (TRIAMCINOLONE SPRAY) WHICH SEEMED TO HELP SOMEWHAT.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 21949286 ↗
• InjuryMay 2, 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 OSTOMY BARRIER FOR OVER THREE YEARS STARTED EXPERIENCING SKIN INFLAMMATION AND REDNESS UNDER THE BARRIER OVER THE LAST MONTH. IT WAS FURTHER REPORTED THAT THE END USER TRIED STEROID SPRAY (TRIAMCINOLONE SPRAY) WHICH SEEMED TO HELP SOMEWHAT.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 21949285 ↗
• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SKIN IRRITATION DEVELOPED UNDER THE BARRIER OF THE HOLLISTER NEW IMAGE SOFT CONVEX OSTOMY BARRIER. IT WAS REPORTED THAT IT HAD BEEN GOING ON FOR SEVERAL MONTHS, NOT SPECIFIC TO ANY PARTICULAR LOT OF PRODUCT, AND HADN'T BEEN CLEARING UP. IT WAS FURTHER REPORTED THAT THEY DIDN'T REALIZE IT WAS FROM EFFLUENT SEEPING UNDER THE BARRIER IRRITATING THE SKIN. IT WAS REPORTED THAT THE END USER WENT TO A DERMATOLOGIST A FEW TIMES AND HE WAS PRESCRIBED A LIQUID TO USE UNDER THE BARRIER ON THE SKIN. IT WAS REPORTED THAT THE DERMATOLOGIST SAID THE SEEPING WAS PROBABLY FROM THE BARRIER NOT ADHERING WELL DUE TO THE PRESENCE OF A HERNIA AND SUGGESTED THEY TRY AN OSTOMY BELT. IT WAS REPORTED THAT THE LIQUID ON THE SKIN IS HELPING, AND THE SKIN IS NOW HEALING.

  Patient problems: Rash

  MAUDE report 21306702 ↗

Other Hollister Incorporated products

• AnchorFast2 models · 70 reports · 1 recall
• Onli16 models · 8 reports · 1 recall
• AnchorFast Guard2 models · 6 reports · 1 recall