KALTOSTATRecalls & reported problems across all models

We found 4 models of KALTOSTAT by Convatec, Purchasing Department in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Sep 16, 2021 and Aug 27, 2026 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (15 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 KALTOSTAT problems

KALTOSTAT models

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

• KALTOSTAT 168212

  Dressing, Wound, Hydrophilic
  10 reports
• KALTOSTAT 168210

  Dressing, Wound, Hydrophilic
  7 reports
• KALTOSTAT 168117

  Dressing, Wound, Hydrophilic
  4 reports
• KALTOSTAT 168214

  Dressing, Wound, Hydrophilic
  3 reports

Recent KALTOSTAT adverse event reports

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

• MalfunctionAug 27, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  The distributor reported that dressings were found not completely sealed. It was unknown whether the product was used on patient or not. Photographs depicting the issue were received from the complainant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50472100 ↗
• MalfunctionAug 27, 2026Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Receipt by User

  The distributor reported that dressings were found not completely sealed. It was unknown whether the product was used on patient or not. Photographs depicting the issue were received from the complainant.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50471902 ↗
• MalfunctionNov 21, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY NURSE THAT THE PATIENT'S DRESSING NEEDED TO BE CHANGED AND FOUNDED THAT THE DRESSING WAS TOO STICKY AND HAD TO BE REMOVED CAREFULLY. NO HARM WAS CAUSED TO THE PATIENT. NO PHOTOGRAPH WAS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23614085 ↗
• MalfunctionNov 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT THERE WERE STAIN ON THE ALGINATE DRESSINGS. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613712 ↗
• MalfunctionNov 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT THERE WERE STAIN ON THE ALGINATE DRESSINGS. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613711 ↗
• MalfunctionNov 21, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT THERE WERE STAIN ON THE ALGINATE DRESSINGS. THE PRODUCT WAS NOT USED. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23613710 ↗
• MalfunctionJun 20, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT, THERE WAS ONE PIECE OF DRESSING FOUND DIRTY. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22296107 ↗
• MalfunctionJun 3, 2025Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  THE DISTRIBUTOR REPORTED THAT, THERE WAS BROWN, DUSTY MATERIAL ON THE DRESSING. THE PRODUCT WAS NOT USED. PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129422 ↗
• MalfunctionJan 19, 2024Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Device Damaged Prior to Use; Packaging Problem

  THE END USER REPORTED THAT ONE OF THE DRESSING WAS OPENED. THE PRODUCT WAS NOT USED BY PATIENT. THE PHOTOGRAPH DEPICTING THE ISSUE WAS ALSO RECEIVED FROM THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18541776 ↗
• MalfunctionNov 8, 2023Nonstandard Device; Nonstandard Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094124 ↗
• MalfunctionNov 8, 2023Nonstandard Device; Nonstandard Device

  TO DATE, ADDITIONAL PATIENT OR EVENT DETAILS WERE RECEIVED WHICH HAVE BEEN ADDED IN H10 (ADDL MFG NARRATIVE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094120 ↗
• MalfunctionNov 8, 2023Nonstandard Device; Nonstandard Device

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18094116 ↗
• MalfunctionJul 25, 2023Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem; Delivered as Unsterile Product; Unsealed Device Packaging; Packaging Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388482 ↗
• MalfunctionJun 27, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17207858 ↗
• MalfunctionJan 6, 2023Delivered as Unsterile Product; Contamination /Decontamination Problem; Delivered as Unsterile Product; Contamination /Decontamination Problem

  TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111154 ↗

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