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PROTEXIS 2D73TE70Recalls & reported problems

Cardinal Health 200, LLC · Sterile Polyisoprene Powder-Free Surgical Gloves with Emollient Coating · Class 1

All models of PROTEXIS (17)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885380024887), received between Nov 21, 2025 and Dec 1, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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: 0 reportsNov 2024: 0 reportsDec 2024: 0 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: 1 reportsDec 2025: 2 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Separation3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 1, 2025Material Separation; Material Separation

    CUSTOMER REPORTED A TEAR INTO TWO PIECES AT THE CUFF ON ONE GLOVE AND AT THE BASE OF THE PALM ON THE LEFT GLOVE DURING DONNING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23687527 ↗
  • MalfunctionDec 1, 2025Material Separation; Material Separation

    CUSTOMER REPORTED THAT THE GLOVE HAD A LEFT TEAR INTO TWO PIECES AT THE BASE OF THE PALM DURING DONNING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23684586 ↗
  • MalfunctionNov 21, 2025Material Separation; Material Separation

    CUSTOMER REPORTED THAT THE GLOVE HAS TORN APART ON LEFT BASE OF PALM DURING DONNING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23622839 ↗

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Sources and updates

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