MEDLINE ES0014MRecalls & reported problems
Medline Industries, Inc. · PTFE COATED BLADE 6' · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 10080196297207), received between Oct 31, 2019 and Oct 31, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Self-Activation or Keying” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Self-Activation or Keying1
Patient problems
- Burn(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 31, 2019Self-Activation or Keying
IT WAS REPORTED THAT WHILE USING THE DEVICE FOR THE FIRST TIME, PRIOR TO PUSHING THE ACTIVATION BUTTON, THE DEVICE ACTIVATED AND BURNED THE PATIENT'S TISSUE.
Patient problems: Burn(s)
MAUDE report 9262698 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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