Medline MDSM611805RRecalls & reported problems
Medline Industries, Inc. · ELECTRODE,RADIOTRANSLUCENT,FOAM,5PK · Class 2
Data updated Oct 18, 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 80884389830429), received between Sep 18, 2026 and Sep 30, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Communication or Transmission Problem” (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
- Adverse Event Without Identified Device or Use Problem1
- Communication or Transmission Problem1
- Device Dislodged or Dislocated1
- Loss of or Failure to Bond1
- Signal Artifact/Noise1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952338 ↗MalfunctionSep 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916622 ↗MalfunctionSep 19, 2026Signal Artifact/Noise; Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50832006 ↗MalfunctionSep 18, 2026Adverse Event Without Identified Device or Use Problem
It was reported that "Experienced a skin reaction, red and itchy. Pads applied for a stress test on various locations on their torso on (b)(6) 2024. Noticed the reaction today, (b)(6). Customer has a latex allergy, but item is marked as not having latex."
Patient problems: Skin Inflammation/ Irritation
MAUDE report 50818078 ↗
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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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