3M™ Red Dot™ 2228Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10707387789524), received between Jun 8, 2023 and Sep 1, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Human-Device Interface Problem” (3 reports).

1 FDA recall record name this device's 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 15, 2020Terminated

   Corrosion could cause performance failures in the product.

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

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 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 ↗
• 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 ↗