Kendall 55535Recalls & reported problems
Cardinal Health, Inc. · Hydrophilic Foam Dressing,Fenestrated · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521020900), received between Jan 8, 2026 and Jan 8, 2026 — classified as 1 malfunction.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 8, 2026
PACKAGE FOUND INTACT WITH A BLACK SUBSTANCE ON THE INSIDE AND ON THE FOAM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24003282 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.