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Halyard 55090Recalls & reported problems

O&M Halyard, Inc. · HALYARD* PURPLE NITRILE-XTRA* Powder-Free Exam Gloves, XS · Class 1

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 20680651550907), received between Oct 30, 2024 and Dec 16, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Incompatible” (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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 1 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Component Incompatible2

Patient problems

  • Contact Dermatitis2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 16, 2024Component Incompatible; Component Incompatible

    THERE WAS A DERMATITIS OUTBREAK/SEVERE REACTION THAT OCCURRED WITH THE END-USER REQUIRING A DOCTOR'S CARE. THERE WERE NO PICTURES OR OTHER INFORMATION MADE AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED ON OCTOBER 18, 2024, OCTOBER 21, 2024, OCTOBER 23, 2024, AND OCTOBER 25, 2024; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

    Patient problems: Contact Dermatitis

    MAUDE report 20940089 ↗
  • InjuryOct 30, 2024Component Incompatible; Component Incompatible

    THERE WAS A DERMATITIS OUTBREAK/SEVERE REACTION THAT OCCURRED WITH THE END-USER REQUIRING A DOCTOR'S CARE. THERE WERE NO PICTURES OR OTHER INFORMATION MADE AVAILABLE. ADDITIONAL INFORMATION WAS REQUESTED ON OCTOBER 18, 2024, OCTOBER 21, 2024, OCTOBER 23, 2024, AND OCTOBER 25, 2024; HOWEVER, NONE HAS BEEN RECEIVED TO DATE.

    Patient problems: Contact Dermatitis

    MAUDE report 20573301 ↗

Other Patient examination glove, specialty devices

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