Red DotRecalls & reported problems across all models

We found 14 models of Red Dot by 3m Company in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Mar 16, 2018 and Apr 10, 2026 — classified as 1 death, 25 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (7 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. 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

Most reported Red Dot problems

Red Dot models

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

• Red Dot™ 2560

  Electrode, electrocardiograph
  5 reports
• Red Dot™ 2670-5

  Electrode, electrocardiograph
  1 death4 reports
• Red Dot™ 2269T

  Electrode, electrocardiograph
  3 reports
• Red Dot™ 2570-5

  Electrode, electrocardiograph
  3 reports
• Red Dot™ 2660-5

  Electrode, electrocardiograph
  3 reports
• Red Dot™ 2255-50

  Electrode, electrocardiograph
  3 reports
• Red Dot™ 2360

  Electrode, electrocardiograph
  2 reports
• Red Dot™ 2238

  Electrode, electrocardiograph
  2 reports
• Red Dot™ 2570

  Electrode, electrocardiograph
  2 reports
• Red Dot™ 2239

  Electrode, electrocardiograph
  1 report
• Red Dot™ 2330

  Electrode, electrocardiograph
  1 report
• Red Dot™ 2660-3

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

  Electrode, electrocardiograph
  1 report
• Red Dot™ 2284

  Electrode, electrocardiograph
  1 report

Recent Red Dot adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026

  A PATIENT PRESENTED FOR A PORTA CATH PLACEMENT (AIRWAY TYPE USED: LARYNGEAL MASK #5). SEVERAL HOURS POST DISCHARGE, PATIENT EXPERIENCED EXCRUCIATING THROAT PAIN & SOUGHT IMMEDIATE MEDICAL ADVICE FOLLOWED BY MEDICAL ATTENTION ON MULTIPLE OCCASIONS. PATIENT ARRIVED AT AN OUTSIDE FACILITY, ED TO OR FOR DIRECT LARYNGOSCOPY W/ [WITH] REMOVAL OF RETAINED LARYNGEAL FOREIGN BODY WHERE A TRANSLUCENT SHEET OF UNKNOWN MATERIAL, 4.0 X 3.5 CM BY LESS THAN 0.1 CM, CORRELATING W/ BACKING OF ELECTRODE USED IN PROCEDURAL AREAS WAS REMOVED JUST ABOVE TRUE VOCAL FOLDS, LODGED AGAINST ARYTENOIDS. PATIENT REPORTED IMMEDIATE IMPROVEMENT IN SYMPTOMS AND DISCHARGED IN STABLE CONDITION. A TRANSLUCENT FOREIGN OBJECT ENTERED THE INTUBATION/SURGICAL FIELD AND WENT UNNOTICED BY THE SURGICAL TEAM BECAUSE IT WAS DIFFICULT TO VISUALLY DETECT. THIS OCCURRED IN PART BECAUSE THE MANUFACTURERS DID NOT EVALUATE VISIBILITY RISKS OF CLEAR MATERIALS WITH NO MARKING.

  Patient problems: Foreign Body In Patient; Sore Throat

  MAUDE report 24839153 ↗
• MalfunctionSep 9, 2024

  PATIENT WITH ACTIVE CHEST PAIN. PROCEDURE ELECTROCARDIOGRAM (EKG). THE EKG ELECTRODES WOULD NOT ADHERE TO PATIENT SKIN. THE ONES THAT DID STICK, WERE NOT CONDUCTING WELL. THIS TOOK ALMOST 15 MINUTES TO GET AN ADEQUATE EKG, DELAY IN PROCEDURE. NO KNOWN HARM TO PATIENT.

  Patient problems: Chest Pain

  MAUDE report 20168414 ↗
• InjuryJan 24, 2024Human-Device Interface Problem; Human-Device Interface Problem

  A PATIENT ALLEGEDLY EXPERIENCED BURNS, SCARRING, SKIN DISCOLORATION, IRRITATION, PAIN, ERYTHEMA, AND RED PEELING SKIN WITH THE USE OF THE 3M¿ RED DOT¿ REPOSITIONABLE MONITORING ELECTRODES. THE PATIENT HAD A HOLTER MONITOR FOR 1 WEEK STARTING ON (B)(6) 2023. FOUR ELECTRODES WERE APPLIED TO THE CHEST AND WERE CHANGED EVERY OTHER DAY. ON (B)(6) 2023 THE PATIENT OBSERVED THE SYMPTOMS AND THE PATIENT'S PHYSICIAN REFERRED HER TO A DERMATOLOGIST. ON THE SAME DAY, (B)(6) 2023, THE DERMATOLOGIST ADMINISTERED PRESCRIBED CLOBETASOL PROP 0.05% CREAM AND STEROID METHYLPREDNISOLONE 4 MG WHICH REPORTEDLY HELPED THE REDNESS AND THE PAIN THAT HAD LASTED FOR 2 WEEKS. THE PATIENT IS ALSO USING AQUAPHOR ON THE SCARS WHICH ARE REPORTEDLY NOT GOING AWAY.

  Patient problems: Burn(s); Erythema; Pain; Peeling; Scar Tissue; Skin Inflammation/ Irritation

  MAUDE report 18576470 ↗
• InjuryAug 30, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A HOSPITAL RISK MANAGER REPORTED A NEONATE ALLEGEDLY EXPERIENCED A 10MM X 10MM LOCALIZED SKIN BURNED/BRUISED WITH A PURPLE/RED APPEARANCE WITH THE USE OF THE 3M¿ RED DOT¿ ECG MONITORING ELECTRODES, NEONATAL, PRE-WIRED, LIMB BAND, 2284. THE WIRE TO THE LEAD WAS REPORTEDLY NOT CONNECTED TO THE ADHESIVE PORTION, APPEARED FRAYED, AND WAS "STUCK" TO THE PATIENT'S SKIN. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Bruise/Contusion; Burn(s)

  MAUDE report 17653215 ↗
• InjuryJun 21, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A 38-YEAR-OLD FEMALE ALLEGEDLY EXPERIENCED A RASH AND AN ITCHING SENSATION WITH THE USE OF THE 3M¿ RED DOT¿ SOFT CLOTH MONITORING ELECTRODE, 2238 LOT 2024-06 XC. THE ELECTRODES WERE SUBSEQUENTLY REMOVED, AND AN ANTI-ALLERGIC, FLUOXETINE OINTMENT WAS APPLIED. THE SYMPTOMS SUBSEQUENTLY RESOLVED THE SAME DAY. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Itching Sensation; Rash

  MAUDE report 17170887 ↗
• InjuryMay 8, 2023Use of Device Problem; Use of Device Problem

  A CUSTOMER REPORTED A PATIENT UNDERWENT TREATMENT AND THE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2570-5 WAS PLACED FOR CARDIAC MONITORING FOR APPROXIMATELY ONE MONTH. THE PATIENT SUBSEQUENTLY EXPERIENCED SCARRING THAT HAS REPORTEDLY NOT SUBSIDED AFTER A FEW DAYS.

  Patient problems: Scar Tissue

  MAUDE report 16887287 ↗
• InjuryMay 3, 2023Human-Device Interface Problem; Human-Device Interface Problem

  A HOSPITAL REPORTED A PATIENT ALLEGEDLY EXPERIENCED A SKIN TEAR POST REMOVAL OF THE 3M¿ RED DOT¿ RESTING EKG ELECTRODE, 2360 LOT 2023-10 NM. THE 3M¿ RED DOT¿ RESTING EKG ELECTRODE REPORTEDLY CONTAINED "AN EXCESSIVE AMOUNT OF ADHESIVE." NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Tears

  MAUDE report 16864287 ↗
• InjuryApr 26, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A HOSPITAL REPORTED A PATIENT ALLEGEDLY EXPERIENCED SKIN DAMAGE WITH THE USE OF THE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2560. ONE WEEK POST APPLICATION OF THE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, THE PATIENT REMOVED THE ELECTRODES AND REPORTEDLY OBSERVED A 2CM X 3CM AREA OF SKIN DAMAGE WITH NO BLEEDING. THE AREA IMPROVED POST DISINFECTION, AND ADMINISTRATION OF MEDICATION, TYPE NOT PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Skin Tears

  MAUDE report 16818219 ↗
• InjuryApr 6, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A CUSTOMER ALLEGED A PATIENT EXPERIENCED CONTACT DERMATITIS WITH BLISTERING THAT REQUIRED TOPICAL TRIAMCINOLONE CREAM TREATMENT AND A DELAY IN SURGERY WITH THE USE OF THE 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2560.

  Patient problems: Blister; Contact Dermatitis

  MAUDE report 16694116 ↗
• InjuryApr 6, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  REPORT RECEIVED FROM THE FDA VIA MEDWATCH FORM MW5115239. A NURSE REPORTED A PATIENT ALLEGEDLY EXPERIENCED A 1-INCH X 0.5 INCH LEFT UPPER CHEST SKIN TEAR WITH ERYTHEMA, AND BLEEDING POST REMOVAL OF 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL 2560, LOT 2024-11 CY THAT REPORTEDLY REQUIRED MEDICAL TREATMENT DESCRIBED AS "FIRST AID." ON POSTOPERATIVE DAY 1, THE SKIN TEAR APPEARED TO BE HEALING WITH SCANT SEROSANGUINOUS DRAINAGE AND SCABBING PRESENT ALONG EDGES OF THE SKIN TEAR. NO PURULENCE OR ACTIVE BLEEDING WAS OBSERVED. THE PATIENT REPORTEDLY HAS A HISTORY OF SKIN SENSITIVITIES DUE TO "THIN SKIN." NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Skin Tears

  MAUDE report 16690433 ↗
• InjuryFeb 13, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A FEMALE PATIENT ALLEGEDLY EXPERIENCED A RIGHT ANKLE SKIN REACTION WITH ERYTHEMA, SORENESS TO THE TOUCH, BLISTERING, WITH POST REMOVAL ITCHY SENSATION WITH THE USE OF 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2560. THE ELECTRODES WERE PLACED UPON HOSPITAL ADMISSION ON (B)(6) 2022. WITHIN A TWO-WEEK PERIOD, THE PATIENT REPORTEDLY HAD "MANY" ELECTRODES APPLIED AT VARIOUS LOCATIONS ON THE BODY THAT WERE CHANGED WHILE THE ANKLE ELECTRODE REMAINED IN PLACE AND WAS NOT CHANGED AT ANY POINT THROUGHOUT THE 2-WEEK HOSPITALIZATION. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH THE ANKLE ELECTRODE REPORTEDLY STILL ATTACHED AND IT WAS NOTED THAT "IT MAY HAVE BEEN LEFT ON ACCIDENTALLY." ON (B)(6) 2023, THE PATIENT REPORTEDLY REMOVED THE ELECTRODE AT HOME AND ALLEGEDLY OBSERVED REDNESS AT THE ANKLE ELECTRODE SITE. ON (B)(6) 2022, A DERMATOLOGIST OBSERVED THE PATIENT AND ADVISED TO APPLY ADVANTAN® CORTICOSTEROID CREAM WHICH REPORTEDLY DID NOT WORK, AS THE RASH WAS ALLEGEDLY SPREADING. THE PATIENT WAS EXPERIENCING REDNESS WITH AN ITCHING SENSATION AND NO SKIN STRIPPING. ON (B)(6) 2023, IT WAS REPORTED THAT TREE OIL WAS APPLIED TWICE TO RELIEVE THE ITCHING

  Patient problems: Blister; Erythema; Itching Sensation; Pain; Rash; Skin Inflammation/ Irritation

  MAUDE report 16363229 ↗
• InjuryFeb 1, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  A 23-YEAR-OLD FEMALE ALLEGEDLY EXPERIENCED AN ANAPHYLACTIC REACTION WITH THE USE OF 3M¿ RED DOT¿ MONITORING ELECTRODE WITH FOAM TAPE AND STICKY GEL, 2570 THAT WAS SUBSEQUENTLY DESCRIBED AS A CHEST URTICARIAL SKIN REACTION. THE PATIENT'S SKIN WAS INITIALLY PREPPED WITH FASTAID® PRE-INJECTION SWAB (70% ISOPROPANOL), THREE ELECTRODES WERE APPLIED TO THE CHEST AREA THAT WERE HELD IN POSITION WITH AN O-FIX STICKER. THE FOLLOWING DAY, AN URTICARIAL SKIN REACTION WAS OBSERVED THAT WAS REPORTEDLY TREATED WITH ANTIHISTAMINES. UPON SUBSEQUENT REPRESENTATION, TONGUE SWELLING WAS IDENTIFIED. THE PATIENT WAS TREATED FOR ANGIOEDEMA WITH ANTIHISTAMINES, STEROIDS, INTRAMUSCULAR ADRENALINE AND WAS TRANSFERRED TO THE ICU [INTENSIVE CARE UNIT]. THE PATIENT REPORTEDLY HAD A "GOOD" RECOVERY. ON DAY THREE, THE PATIENT WAS TRANSFERRED TO THE WARD AND WAS SUBSEQUENTLY DISCHARGED HOME ON DAY FIVE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 16279496 ↗
• InjuryDec 5, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  A 2-WEEK-OLD FEMALE EXPERIENCED LEFT CHEST/AXILLARY ERYTHEMA, EDEMA, RASH, SKIN TEARS, MACERATION, PURULENT DRAINAGE AND A 3CM X 6CM BLISTER, LESS THAN 24-HOURS POST APPLICATION OF 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TAPE, 2269T LOT 202407AB. MEDICAL TREATMENT WAS REPORTEDLY REQUIRED AND WAS NOTED AS WOUND CARE. EXUFIBER® AG+ WITH HYDROLOCK® AND ALLEVYN SILICONE DRESSINGS WERE APPLIED FOR 4 DAYS, AS THE BLISTERS DRAINED THE PURULENT FLUID. SUBSEQUENTLY, THE ALLEVYN SILICONE DRESSINGS WERE UTILIZED FOR 3 ADDITIONAL DAYS. THE SYMPTOMS REPORTEDLY RESOLVED AFTER 5 DAYS.

  Patient problems: Blister; Erythema; Purulent Discharge; Rash; Skin Maceration; Skin Tears; Swelling/ Edema

  MAUDE report 15916126 ↗
• InjuryDec 4, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  A 5-WEEK-OLD MALE EXPERIENCED LEFT UPPER CHEST ERYTHEMA, SKIN TEARS, MACERATION, AND A 4CM X 4CM BLISTER IN LESS THAN 24-HOURS POST APPLICATION OF 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TAPE, 2269T LOT: 202407AB. MEDICAL TREATMENT WAS REPORTEDLY REQUIRED DESCRIBED AS WOUND CARE THAT INCLUDED TREATMENT WITH 3M¿ CAVILON¿ NO STING BARRIER FILM, AND THE SYMPTOMS SUBSEQUENTLY RESOLVED AFTER THREE DAYS.

  Patient problems: Blister; Erythema; Skin Maceration; Skin Tears

  MAUDE report 15912441 ↗
• InjuryNov 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  A 3-WEEK-OLD FEMALE EXPERIENCED LEFT LOWER CHEST ERYTHEMA, EDEMA, SKIN TEARS, MACERATION AND TWO BLISTERS WITH PURULENT DRAINAGE 24-HOURS POST APPLICATION OF 3M¿ RED DOT¿ NEONATAL, PRE-WIRED, RADIOLUCENT MONITORING ELECTRODE WITH CLEAR TAPE, 2269T. MEDICAL TREATMENT WAS REPORTEDLY REQUIRED AND WAS NOTED AS WOUND CARE CONSULT. EXUFIBER® AG+ WITH HYDROLOCK® AND ALLEVYN SILICONE DRESSINGS WERE APPLIED FOR 4 DAYS, AS THE BLISTERS DRAINED THE PURULENT FLUID. SUBSEQUENTLY, ALLEVYN SILICONE DRESSINGS WERE UTILIZED FOR 3 ADDITIONAL DAYS.

  Patient problems: Blister; Erythema; Purulent Discharge; Skin Maceration; Skin Tears; Swelling/ Edema

  MAUDE report 15876389 ↗

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