MEDLINE SIL1455Recalls & reported problems
Medline Industries, Inc. · ELECTRODE, BLADE, 2.75', SIL-INS · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489015898), received between Sep 23, 2026 and Sep 24, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Material Protrusion/Extrusion1
- Material Puncture/Hole1
- Melted1
- Peeled/Delaminated1
- Sparking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Burn(s)1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Sparking
It was reported that "the product started to spark while being used. The facility has deemed these unsafe for use now and would like to return them for a credit."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50884876 ↗MalfunctionSep 24, 2026Crack; Melted; Material Puncture/Hole
It was reported that the side of electrode melted and exposed a hole in the insulation and noticed a small crack leading to the base of the tip. The location of the tip that failed: ¿right above the dark blue part of plastic¿.
Patient problems: Burn(s)
MAUDE report 50883283 ↗MalfunctionSep 23, 2026Peeled/Delaminated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863073 ↗MalfunctionSep 23, 2026Material Protrusion/Extrusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863071 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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