Medline MDSM611300Recalls & reported problems
Medline Industries, Inc. · ELECTRODE,REPOSITIONABLE,MEDGEL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277399389), received between Sep 9, 2026 and Sep 15, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (4 reports).
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
- Loss of or Failure to Bond4
- Device Dislodged or Dislocated1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 15, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50777248 ↗MalfunctionSep 15, 2026Device Dislodged or Dislocated
It was reported that clinical staff have stated that they fall off on all patients regardless of how they apply them.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50771209 ↗MalfunctionSep 14, 2026Mechanical Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50762640 ↗MalfunctionSep 14, 2026Loss of or Failure to Bond
It was reported that these are not sticking to the patient's skin.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50748019 ↗MalfunctionSep 11, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736201 ↗MalfunctionSep 9, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50701616 ↗
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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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