Red Dot™ 2238Recalls & reported problems
3m Company · 3M™ Red Dot™ Soft Cloth Monitoring Electrode, 50/Bag, 20/Case, 66 Plt 2238 · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10707387206311), received between Mar 16, 2018 and Jun 21, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Human-Device Interface Problem” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Human-Device Interface Problem1
Patient problems
- Itching Sensation2
- Burning Sensation1
- Erythema1
- Rash1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗InjuryMar 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A HOSPITAL INPATIENT REPORTED SHE EXPERIENCED REDNESS, BURNING AND ITCHING WHEN 3M¿ 2238 RED DOT¿ ELECTRODES WERE APPLIED TO HER CHEST FOR CARDIAC MONITORING. SHE ALLEGEDLY HAS 18-20 BRIGHT RED CIRCULAR MARKS ON HER CHEST WHERE THE ELECTRODES WERE PLACED. AN UNSPECIFIED TOPICAL OINTMENT WAS USED FOR TREATMENT.
Patient problems: Burning Sensation; Erythema; Itching Sensation
MAUDE report 7346409 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.