Medline MDS200100Recalls & reported problems
Medline Industries, Inc. · STRIP,STEAM INDICATOR,4" · Class 2
- 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 30080196729580), received between Sep 18, 2026 and Sep 18, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Fragmentation” (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
- Material Fragmentation1
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.
MalfunctionSep 18, 2026Material Fragmentation
It was reported that "during sterilization the indicator strip is sticking to the bottom of the tray. Pieces of the indicator break off during sterilization and get stuck in the drain of the sterilizer."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50813087 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.