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Halyard 41660Recalls & reported problems

O&M Halyard, Inc. · HALYARD* STERLING SG* Powder-Free Nitrile Exam Glove, L · Class 1

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 20680651416609), received between Aug 29, 2017 and Aug 29, 2017 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Reaction1

Recent adverse event reports

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

  • InjuryAug 29, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A CUSTOMER ALLEGED HAVING AN ALLERGIC REACTION FROM WEARING GLOVES THAT INVOLVED DIFFICULTY BREATHING, NUMBNESS AND TINGLING OF THE LIPS. PER THE CUSTOMER THE GLOVES WERE WORN FOR FIVE MINUTES PRIOR TO HAVING A REACTION. BENADRYL WAS TAKEN FOR THE SYMPTOMS THAT LASTED FOR 45 MINUTES AFTER THE GLOVES WERE TAKEN OFF. THE CUSTOMER¿S HANDS WERE ITCHY BUT NO RASH, HIVES OR MEDICAL INTERVENTION REPORTED. THE CUSTOMER IS REPORTED TO BE IN STABLE CONDITION. THE CUSTOMER IS ALLERGIC TO PENICILLIN AND FISH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: Reaction

    MAUDE report 6827209 ↗

Other Patient examination glove, specialty devices

All Patient examination glove, specialty devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.