3M™ Red Dot™ 2560Recalls & reported problems
3m Company · 3M™ Red Dot™ ECG Monitoring Electrodes, 2560, Foam, Diaphoretic, 1.57 in x 1.38 in (4cm x 3,5cm), 50 ea/Bag, 20 Bag/Case · Class 2
All models of 3M Red Dot (8)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10707387789302), received between Nov 27, 2024 and Dec 9, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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
- Difficult to Remove1
- Output Problem1
Patient problems
- Pain1
- Skin Inflammation/ Irritation1
- Skin Tears1
- Unspecified Tissue Injury1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 9, 2025Difficult to Remove; Output Problem
WHEN REMOVING ELECTRODES, VERY HARD TO REMOVE RESULTING IN SKIN TEAR OF PATIENT.
Patient problems: Unspecified Tissue Injury
MAUDE report 23756886 ↗MalfunctionJan 8, 2025
PATIENT HAD AN ELECTROCARDIOGRAM (ECG OR EKG) PERFORMED IN THE EMERGENCY DEPARTMENT (ED). ACCORDING TO PATIENT, WHEN THE NURSE REMOVED THE ELECTRODE THE ADHESIVE REMOVED SKIN. THE EKG TECH ALSO PERFORMED AN EKG, AND COULD NOT REMOVE ONE OF THE ELECTRODES EVEN WITH THE HELP OF AN ALCOHOL PAD. THE PATIENT ASKED HER TO LEAVE IT AND SHE WOULD REMOVE IT IN THE SHOWER. THE EKG TECHS BELIEVE THE ADHESIVE ON THE MULTI-PACKS OF EKG ELECTRODES IS NOW MUCH MORE STICKY THAN BEFORE.
Patient problems: Skin Tears
MAUDE report 21102014 ↗MalfunctionNov 27, 2024
RECENTLY THERE HAS BEEN A CHANGE WITH THE LEVEL OF ADHESIVE ON THE RED DOT STICKERS (2560) USED TO PERFORM ELECTROCARDIOGRAMS (EKGS). THE STICKERS ARE MUCH MORE STICKIER, THERE IS LESS GEL IN THE CENTER, AND WE'VE HAD TROUBLE GETTING THEM OFF OF PATIENTS RESULTING IN MORE PAIN FOR THE PATIENT. THIS MORNING I DID AN EKG ON A PATIENT ¿ I WENT TO REMOVE THE STICKER FROM THE LEFT ARM HOWEVER, IT WOULD NOT BUDGE BECAUSE OF HER THIN SKIN AND THE AMOUNT OF ADHESIVE. I HAD TO USE DETACHOL TO REMOVE THE STICKER WHICH TOOK ME ABOUT TWO MINUTES TO DO BECAUSE I DIDN'T WANT TO TEAR HER SKIN. ITS ALSO CAUSING IRRITATION, MORE PAIN, AND WE ARE HAVING MORE TROUBLE GETTING THE MACHINE TO READ THE RHYTHMS.
Patient problems: Pain; Skin Inflammation/ Irritation
MAUDE report 20795794 ↗
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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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