3M™ Red Dot™ 2238Recalls & reported problems
3m Company · 3M™ Red Dot™ Soft Cloth Monitoring Electrode, 2238, 2.4 inch dia. (6cm dia.), (50 Each/Bag, 20 Bag/Case) · 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 10707387788848), received between Jul 18, 2023 and Jul 31, 2023 — classified as 2 injuries.
The most frequently reported specific device problem is “Human-Device Interface Problem” (2 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, 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
- Human-Device Interface Problem2
Patient problems
- Itching Sensation2
- Skin Discoloration2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
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 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.