ACTIVELIFERecalls & reported problems across all models
Convatec, Purchasing Department · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ACTIVELIFE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 437
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 2
We found 21 models of ACTIVELIFE by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 437 adverse event reports in the FDA's MAUDE database, received between Oct 9, 2018 and Nov 20, 2025 — classified as 2 injuries, 435 malfunctions.
The most frequently reported specific device problem is “Malposition of Device” (431 reports).
2 FDA recall records name at least one of these models by its device identifier, 2 still open.
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
Reports received per month, all models
ACTIVELIFE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Aug 16, 2022Open, Classified
impaired functionality of the release liner
Z-0130-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Aug 16, 2022Open, Classified
impaired functionality of the release liner
Z-0129-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported ACTIVELIFE problems
Device problems
- Malposition of Device431
- Positioning Problem26
- Peeled/Delaminated5
- Positioning Failure5
- Fluid/Blood Leak4
- Sharp Edges4
- Adverse Event Without Identified Device or Use Problem1
- Device Handling Problem1
Patient problems
- No Consequences Or Impact To Patient265
- No Clinical Signs, Symptoms or Conditions64
- No Patient Involvement38
- Tissue Damage34
- Distress25
- Blood Loss19
- Skin Irritation8
- Tissue Breakdown2
ACTIVELIFE models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACTIVELIFE 022767Bag, drainage, with adhesive, ostomy60 reports
- ACTIVELIFE 022765Bag, drainage, with adhesive, ostomy53 reports
- ACTIVELIFE 400598Bag, drainage, with adhesive, ostomy1 recall0 reports
- ACTIVELIFE 400599Bag, drainage, with adhesive, ostomy1 recall0 reports
- ACTIVELIFE 650831BAG, URINARY, ILEOSTOMY44 reports
- ACTIVELIFE 175777POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175778POUCH, COLOSTOMY40 reports
- ACTIVELIFE 175779POUCH, COLOSTOMY39 reports
- ACTIVELIFE 650832BAG, URINARY, ILEOSTOMY26 reports
- ACTIVELIFE 175791BAG, URINARY, ILEOSTOMY22 reports
- ACTIVELIFE 125365BAG, URINARY, ILEOSTOMY20 reports
- ACTIVELIFE 175782POUCH, COLOSTOMY19 reports
- ACTIVELIFE 175792BAG, URINE COLLECTING, URETEROSTOMY19 reports
- ACTIVELIFE 175793BAG, URINARY, ILEOSTOMY12 reports
- ACTIVELIFE 022769Bag, drainage, with adhesive, ostomy10 reports
- ACTIVELIFE 175780POUCH, COLOSTOMY10 reports
- ACTIVELIFE 650830BAG, URINARY, ILEOSTOMY9 reports
- ACTIVELIFE 022771Bag, drainage, with adhesive, ostomy7 reports
- ACTIVELIFE 175784POUCH, COLOSTOMY5 reports
- ACTIVELIFE 175790Bag, Urinary, Ileostomy1 report
- ACTIVELIFE 175794BAG, URINARY, ILEOSTOMY1 report
Recent ACTIVELIFE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602270 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
THE CONSUMER¿S WIFE REPORTED THAT THE MASS WAS OFF-CENTER. THERE WERE FIVE POUCHES FROM THIS BOX. SHE STATED THAT SHE HAD NOT USED ANY FROM THIS BOX BECAUSE OF FEAR THAT THE POUCH WOULD SEPARATE FROM THE MASS. PHOTOS WERE REQUESTED, AND A REPLACEMENT WAS PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602268 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602267 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
THE CONSUMER¿S WIFE REPORTED THAT THE MASS WAS OFF-CENTER. THERE WERE FIVE POUCHES FROM THIS BOX. SHE STATED THAT SHE HAD NOT USED ANY FROM THIS BOX BECAUSE OF FEAR THAT THE POUCH WOULD SEPARATE FROM THE MASS. PHOTOS WERE REQUESTED, AND A REPLACEMENT WAS PROVIDED. NO PHOTO IS AVAILABLE AT THIS TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602266 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
THE CONSUMER¿S WIFE REPORTED THAT THE MASS WAS OFF-CENTER AND THE POUCH DETACHED FROM THE MASS AS A RESULT, CAUSING ODOR. THERE WERE FIVE POUCHES FROM THIS BOX. SHE STATED THAT ALL WERE OFF-CENTER, BUT THREE HAD BEEN USED AND WERE SLIGHTLY SEPARATED FROM THE MASS. THEY SEEMED TO CATCH THE ISSUE BEFORE LEAKAGE OF EFFLUENT OCCURRED. THE MASS REMAINED ADHERED WELL TO THE SKIN. THE CONSUMER USED AN APPLIANCE BELT AND PLACED ODOR ELIMINATOR DROPS IN THE POUCH. ACCORDING TO THE CASE HISTORY, SHE MENTIONED THIS HAD BEEN AN ONGOING ISSUE, WHICH WAS RESOLVED FOR A WHILE BUT HAD STARTED OCCURRING AGAIN. SHE ALSO REPORTED A SECOND LOT ON THE SAME DAY. PHOTOS WERE REQUESTED, AND A REPLACEMENT WAS PROVIDED. NO HARM WAS REPORTED, BUT THEY INDICATED HAVING TO USE MANY MORE POUCHES THAN TYPICAL (WEAR TIME COULD BE ALMOST A WEEK WHEN THIS ISSUE WAS NOT OCCURRING). THE CONSUMER HAD BEEN USING THE PRODUCT FOR MANY YEARS. NO PHOTO WAS AVAILABLE AT THAT TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602265 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602264 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602263 ↗MalfunctionNov 20, 2025Malposition of Device; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602262 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602207 ↗MalfunctionNov 20, 2025Positioning Failure; Peeled/Delaminated; Malposition of Device; Positioning Failure; Peeled/Delaminated; Malposition of Device
TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23602205 ↗MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295019 ↗MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295018 ↗MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295016 ↗MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295015 ↗MalfunctionFeb 3, 2025Malposition of Device; Malposition of Device
THE END USER REPORTED THAT MOST OF THE APPLIANCES FROM THE TEN BOXES HAD OFF-CENTERED STARTER HOLES AND WERE NOT USABLE. THE END USER REPORTED THAT AS MOST OF THE STARTER HOLES WERE AFFECTED AND HE MUST SORT THROUGH THE BOXES TO FIND ONES THAT HE COULD USE. HE DID NOT USE THE PRODUCTS THAT WERE WITH OFF-CENTERED STARTER HOLES. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21295014 ↗
Other Convatec, Purchasing Department products
- DUODERM9 models · 7,142 reports · 1 recall
- SUR-FIT NATURA43 models · 6,207 reports · 2 recalls
- NATURA15 models · 5,161 reports
- CURE CATHETER25 models · 862 reports
- GENTLECATH GLIDE9 models · 572 reports
- ESTEEM52 models · 200 reports · 7 recalls
- GENTLECATH8 models · 430 reports
- ESTEEM SYNERGY9 models · 241 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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