MEDLINE INDUSTRIES, INC. MDSM616201Recalls & reported problems
Medline Industries, Inc. · ELECTRODE,ECG,TAB,10/CARD,5000/CS, ADULT · Class 2
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 80888277352338), received between Sep 9, 2026 and Sep 30, 2026 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (9 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond9
- Adhesive Too Strong2
- Connection Problem1
- Device Dislodged or Dislocated1
- Device Emits Odor1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- Local Reaction1
- Skin Burning Sensation1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952383 ↗MalfunctionSep 30, 2026Mechanical Problem; Device Emits Odor
It was reported that "STRONG CHEMICAL SMELL AND ALLERGIC REACTION TO PATIENTS SKIN ALSO DOES NOT STICK WELL."
Patient problems: Local Reaction; Skin Burning Sensation
MAUDE report 50947304 ↗MalfunctionSep 29, 2026Loss of or Failure to Bond
It was reported that the electrodes do not stick.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937407 ↗MalfunctionSep 23, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50870709 ↗MalfunctionSep 21, 2026Adhesive Too Strong
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842314 ↗MalfunctionSep 18, 2026Adhesive Too Strong
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828629 ↗MalfunctionSep 18, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820922 ↗MalfunctionSep 16, 2026Connection Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50795874 ↗MalfunctionSep 15, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50774212 ↗MalfunctionSep 13, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746978 ↗MalfunctionSep 12, 2026Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746756 ↗MalfunctionSep 12, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50746672 ↗MalfunctionSep 10, 2026Loss of or Failure to Bond
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50717987 ↗MalfunctionSep 9, 2026Loss of or Failure to Bond
It was reported that the EKG electrodes "do not stick to the patient¿s chest and come off easily" and "in the middle of the test, the electrodes still come off."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50691503 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.