KALTOSTAT 168212Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00768455122790), received between Aug 8, 2022 and Aug 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (9 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, 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 ↗
• 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 ↗
• MalfunctionAug 8, 2022Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem

  IT WAS REPORTED THAT PRIMARY PACKAGE WAS SEALED WITH PRODUCT. THE DEVICE WAS NOT USED BY END USER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15181887 ↗