DUODERMRecalls & reported problems across all models
Convatec, Purchasing Department · 9 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one DUODERM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7,142
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 9 models of DUODERM by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 7,142 adverse event reports in the FDA's MAUDE database, received between May 2, 2019 and Sep 30, 2026 — classified as 7,142 malfunctions.
The most frequently reported specific device problem is “Delivered as Unsterile Product” (6,909 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 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
DUODERM 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 29, 2025Class IIOpen, Classified
Wound dressing may have foreign matter on the product.
Z-0160-2026 · Root cause: Process control · Recall details · FDA record ↗
Most reported DUODERM problems
Device problems
- Delivered as Unsterile Product6,909
- Contamination /Decontamination Problem6,635
- Packaging Problem341
- Device Damaged Prior to Use309
- Unsealed Device Packaging216
- Difficult to Remove90
- Tear, Rip or Hole in Device Packaging68
- Nonstandard Device65
Patient problems
- No Clinical Signs, Symptoms or Conditions7,051
- Tissue Breakdown64
- Skin Tears61
- Skin Inflammation/ Irritation25
- Distress14
- Erythema10
- Laceration(s)10
- Rash10
DUODERM models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DUODERM 187957Dressing, Wound, Occlusive4,342 reports
- DUODERM 187955Dressing, Wound, Occlusive1 recall2,348 reports
- DUODERM 187660Dressing, Wound, Occlusive207 reports
- DUODERM 187961Dressing, Wound, Occlusive153 reports
- DUODERM 187662Dressing, Wound, Occlusive43 reports
- DUODERM 187900Dressing, Wound, Occlusive25 reports
- DUODERM 187644Dressing, Wound, Occlusive15 reports
- DUODERM 187661Dressing, Wound, Occlusive8 reports
- DUODERM 187932Dressing, Wound, Occlusive1 report
Recent DUODERM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951282 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951277 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951276 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951274 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951266 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951263 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951261 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951257 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951255 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951094 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
The distributor reported that the colored dot was found on fifty-nine dressings. The product was not used. The photographs depicting the issue were received from the complainant.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951093 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951092 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951090 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951087 ↗MalfunctionSep 30, 2026Delivered as Unsterile Product; Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951081 ↗
Other Convatec, Purchasing Department products
- 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
- ACTIVELIFE21 models · 437 reports · 2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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