3M Red DotRecalls & reported problems across all models

We found 8 models of 3M Red Dot by 3m Company in the FDA's device registry (GUDID). Together they are named in 16 adverse event reports in the FDA's MAUDE database, received between Jun 21, 2021 and Dec 9, 2025 — classified as 12 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Human-Device Interface Problem” (9 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

3M Red Dot recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 15, 2020Terminated

   Corrosion could cause performance failures in the product.

   Z-0423-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported 3M Red Dot problems

3M Red Dot models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• 3M™ Red Dot™ 2228

  Electrode, electrocardiograph
  1 recall4 reports
• 3M™ Red Dot™ 2560

  Electrode, electrocardiograph
  3 reports
• 3M™ Red Dot™ 2238

  Electrode, electrocardiograph
  2 reports
• 3M™ Red Dot™ 2670-5

  Electrode, electrocardiograph
  2 reports
• 3M™ Red Dot™ 2670-3

  Electrode, electrocardiograph
  2 reports
• 3M™ Red Dot™ 2660-3

  Electrode, electrocardiograph
  1 report
• 3M™ Red Dot™ 2570-5

  Electrode, electrocardiograph
  1 report
• 3M™ Red Dot™ 2268-3

  Electrode, electrocardiograph
  1 report

Recent 3M Red Dot adverse event reports

The 15 most recent reports across all models, 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 ↗
• InjuryMar 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A CUSTOMER PRESENTED TO THE HOSPITAL FOR DIZZINESS DUE TO POTENTIAL HEART ISSUES AND 3M¿ RED DOT¿ ECG MONITORING ELECTRODES, 2670-3 WERE ALLEGEDLY APPLIED FOR HEART MONITORING. TWO DAYS POST ELECTRODE APPLICATION, THE PATIENT ALLEGEDLY EXPERIENCED REDNESS, PAIN, BLISTERING, SEVERE BURNS WITH SCARRING. THE CUSTOMER PRESENTED TO URGENT CARE THE SAME DAY, WAS DIAGNOSED WITH A 2CM X 2CM LEFT UPPER CHEST ERYTHEMATOUS CHEMICAL BURN WITH BLISTERING, AND WAS DISCHARGED THE SAME DAY WITH A TREATMENT PLAN NOTED AS APPLICATION OF SILVER SULFADIAZINE 1% EXTERNAL CREAM, TWICE A DAY FOR 10 DAYS, 8 GRAMS.

  Patient problems: Caustic/Chemical Burns

  MAUDE report 18994902 ↗
• InjurySep 1, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 6-MONTH-OLD MALE PATIENT WAS ADMITTED TO HOSPITAL ECG MONITORING WAS PERFORMED WITH 3M RED DOT ELECTRODES, 2228, LOT 2025-01 LI. MID-MORNING THE SAME DAY, A 2X2CM SKIN RASH HIGHER THAN THE SKIN SURFACE WITH LOCALIZED REDNESS AND SWELLING APPEARED AT THE ELECTRODE APPLICATION SITE. THE ELECTRODES WERE REPLACED/APPLIED TO A DIFFERENT SITE AND ERYTHROMYCIN OINTMENT WAS APPLIED ON THE AFFECTED AREA.

  Patient problems: Erythema; Rash; Swelling/ Edema

  MAUDE report 17670910 ↗
• InjuryAug 31, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 73-YEAR-OLD MALE WEIGHING 290 LBS ALLEGEDLY EXPERIENCED AN APPROXIMATELY 1" SKIN TEAR ON LEFT FOREARM WITH ECCHYMOSIS AND BLEEDING 45 MINUTES POST APPLICATION OF THE 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE, 2670-5, LOT 202408TE, THAT REQUIRED MEDICAL TREATMENT DESCRIBED AS "CLEANED AND DRESSED" IN ORDER TO TREAT A MINOR INJURY, AND NOT TO PREVENT A SERIOUS INJURY. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Ecchymosis; Hemorrhage/Blood Loss/Bleeding; Skin Tears

  MAUDE report 17662954 ↗
• InjuryAug 31, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 82-YEAR-OLD MALE WEIGHING 160 LBS ALLEGEDLY EXPERIENCED LOCALIZED BRUISING ON THE LEFT FOREARM AND RIGHT WRIST WITH A 1.5 CM LEFT FOREARM SKIN TEAR 30 MINUTES POST APPLICATION OF THE 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODE, 2670-5, LOT 202408TE, THAT REQUIRED MEDICAL TREATMENT DESCRIBED AS "CLEANED AND DRESSED" IN ORDER TO TREAT A MINOR INJURY, AND NOT TO PREVENT A SERIOUS INJURY. THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Ecchymosis; Skin Tears

  MAUDE report 17661471 ↗
• InjuryAug 4, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 76-YEAR-OLD MALE ALLEGEDLY EXPERIENCED A LOCALIZED ITCHING SENSATION WITH REDNESS AND SWELLING ONE HOUR POST APPLICATION OF THE 3M¿ ECG MONITORING ELECTRODES, FOAM DIAPHORETIC, 2228 LOT 2025-01 LI. THE ELECTRODES WERE REMOVED, AND PRESCRIBED COMPOUND DEXAMETHASONE ACETATE CREAM WAS APPLIED LOCALLY. THE REDNESS AND SWELLING SUBSEQUENTLY SUBSIDED WITHOUT ANY OTHER DISCOMFORT.

  Patient problems: Erythema; Itching Sensation; Swelling/ Edema

  MAUDE report 17460201 ↗
• InjuryJul 31, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A PATIENT ALLEGEDLY EXPERIENCED LOCALIZED SKIN FLUSHING AND AN ITCHING SENSATION ONE DAY POST APPLICATION OF THE 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE, 2238 LOT 20220607. THE ELECTRODES WERE REMOVED, PRESCRIBED TOPICAL FLUOCINOLONE OINTMENT WAS APPLIED, AND THE SYMPTOMS RESOLVED THE FOLLOWING DAY.

  Patient problems: Itching Sensation; Skin Discoloration

  MAUDE report 17430926 ↗
• InjuryJul 18, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 42-YEAR-OLD MALE ALLEGEDLY EXPERIENCED FLUSHING AND AN ITCHING SENSATION WITH THE USE OF 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE, 2238. THE ELECTRODES WERE REMOVED, PRESCRIBED TOPICAL FLUOCINOLONE OINTMENT WAS APPLIED, AND THE SYMPTOMS RESOLVED THE SAME DAY.

  Patient problems: Itching Sensation; Skin Discoloration

  MAUDE report 17345279 ↗
• InjuryJun 21, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 30-YEAR-OLD MALE ALLEGEDLY EXPERIENCED A SERIOUS INJURY NOTED AS REDNESS AND AN ITCHING SENSATION WITH THE USE OF THE 3M¿ ECG MONITORING ELECTRODES, FOAM DIAPHORETIC, 2228 LOT: 20220504. THE AREA WAS WIPED WITH ALCOHOL AND AN INTRAVENOUS INFUSION OF ANTI-ALLERGIC MEDICINE WAS ADMINISTERED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Erythema; Itching Sensation

  MAUDE report 17170722 ↗
• InjuryJun 8, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A 41-YEAR-OLD FEMALE ALLEGEDLY EXPERIENCED A LOCALIZED ALLERGIC REACTION WITH A REDNESS, RASH, AND AN ITCHING SENSATION APPROXIMATELY FIVE HOURS POST APPLICATION OF THE 3M¿ FOAM MONITORING ELECTRODE 2228 LOT (B)(6) 2024 LA. THE ELECTRODES WERE SUBSEQUENTLY REMOVED, AND A TOPICAL MEDICINE WAS APPLIED, TYPE NOT PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Rash

  MAUDE report 17091523 ↗
• InjuryMay 23, 2023Human-Device Interface Problem; Human-Device Interface Problem

  REPORT RECEIVED VIA MEDWATCH 4900240000-2023-8070: A HOSPITAL REPORTED A FEMALE PATIENT ALLEGEDLY EXPERIENCED SKIN REMOVAL, IRRITATION WITH ERYTHEMA AND A RASH WITH THE USE OF THE 3M¿ RED DOT¿ ELECTRODE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Erythema; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 16988958 ↗
• InjuryMay 11, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A HOSPITAL REPORTED "SOME" PATIENTS ALLEGEDLY EXPERIENCED SKIN TEARING WITH THE USE OF THE 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODE, 2670-3. THE ELECTRODE LEADS ARE REPORTEDLY DIFFICULT TO REMOVE AFTER A SHORT DURATION OF USE, EVEN WITH THE USE OF AN ADHESIVE REMOVER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 16911090 ↗
• MalfunctionSep 21, 2022Signal Artifact/Noise

  3M ECG PADS PHYSICALLY DRY, POOR SIGNAL CONDUCTION FOR ECG. PADS WERE REMOVED FROM A SEALED PACKAGE. DELAYED START TIME FOR CARDIOVASCULAR OPERATING ROOM. ACTUAL PADS NOT SAVED. PICTURE IS REPRESENTATION FOR THE PRODUCT, BOTH FROM THE SAME BOX WITH THE SAME LOT #. MANUFACTURER RESPONSE FOR ECG PAD, (BRAND NOT PROVIDED) (PER SITE REPORTER). WILL WATCH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15461653 ↗

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