MEDLINE MSC3044Recalls & reported problems
Medline Industries, Inc. · DRESSING,STRATASORB,COMP,ISLAND,4"X4" · Class 1
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10080196669417), received between Sep 24, 2026 and Sep 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).
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
Device problems
- Loss of or Failure to Bond1
- Patient Device Interaction Problem1
Patient problems
- Blister1
- No Clinical Signs, Symptoms or Conditions1
- Rash1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Loss of or Failure to Bond
It was reported that "the stratasorb falls off even with proper wound/periskin cleansing with our skintegrity wound cleanser and skin prep application to the periwound after patting the area dry."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915424 ↗MalfunctionSep 24, 2026Patient Device Interaction Problem
It was reported that the Stratasorb dressings are causing skin reactions including blistering and rashes in orthopedic patients. They also indicated there have been repeated incidents.
Patient problems: Blister; Rash
MAUDE report 50886190 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.