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S&N REMOVE WIPES CE MARKED 59403125Recalls & reported problems

Smith & Nephew Medical Limited · Universal Adhesive Remover Wipes · Class 1

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00040565120287), received between Feb 27, 2021 and Feb 27, 2021 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Burn(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryFeb 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A BURN OCCURRED ON A (B)(6) AS A RESULT OF USING REMOVE WIPES IN COMBINATION WITH ELECTRODES (WITH GEL) (CARDINALHEALTH KENDALL NEONATAL ECG ELECTRODES). THE WIPES WERE ONLY USED ONE TIME WHEN THE REACTION OCCURRED. IT IS UNKNOWN HOW THE BURN WAS TREATED BUT THE WIPES STOPPED BEING USED DIRECTLY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

    Patient problems: Burn(s)

    MAUDE report 11389517 ↗

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Sources and updates

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