Medline PAD9165LRecalls & reported problems
Medline Industries, Inc. · GROUNDING, UNIVERS, SPLIT, 15'CORD · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489082548), received between Aug 13, 2025 and Sep 28, 2026 — classified as 1 injury, 4 malfunctions.
The most frequently reported specific device problem is “Adhesive Too Strong” (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.
Reports received per month
Most reported problems
Device problems
- Adhesive Too Strong1
- Break1
- Complete Loss of Power1
- Grounding Malfunction1
- Material Split, Cut or Torn1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Full thickness (Third Degree) Burn1
- Insufficient Information1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Break
It was reported that "they are having issues with the plug-in keeping signal and having to be held in."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915276 ↗MalfunctionSep 15, 2026Adhesive Too Strong
It was reported that "The adhesive on the pad is too sticky to the protective plastic, yet it does not adhere well to the patient."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774570 ↗MalfunctionSep 8, 2026Material Split, Cut or Torn; Physical Resistance/Sticking
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50670037 ↗MalfunctionMay 12, 2026Complete Loss of Power
CUSTOMER STATED THEY TRIED 3 PAD AND 2 BOVIE MACHINES AND THEY WOULDN'T LET US USE THE BOVIE. THE LIGHT STAYED RED. THEY USED THE SAME MACHINE AND A DIFFERENT LOT NUMBER PAD AND IT WORKED.
Patient problems: Insufficient Information
MAUDE report 25156869 ↗InjuryAug 13, 2025Grounding Malfunction; Grounding Malfunction
IT WAS REPORTED THAT A PATIENT SUFFERED A THIRD DEGREE BURN TO THE RIGHT LATERAL THIGH WHERE A GROUNDING PAD WAS PLACED.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 22794851 ↗
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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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