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MEDLINE INDUSTRIES, INC. DYNJ66529BRecalls & reported problems

Medline Industries, Inc. · ANGIOGRAPHY DRAPE PACK · Class 2

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

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10198459472831), received between Jan 13, 2026 and Jan 15, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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: 0 reportsDec 2025: 0 reportsJan 2026: 2 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

  • Break2

Patient problems

  • Exposure to Body Fluids1
  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionJan 15, 2026Break

    IT WAS REPORTED THAT A "SYRINGE BROKE DURING A PROCEDURE CAUSING BLOOD TO SPLASH ON THE OPERATOR". THE CUSTOMER REPORTED THAT THE CLINICIAN WAS "CLEARING A SYRINGE OF PATIENT'S BLOOD AND IT SHATTERED AND BLOODY FLUID SPRAYED AROUND INCLUDING ON MY FACE AND A FEW DROPLETS IN MY EYE." THE CUSTOMER STATED THAT THE SYRINGE BROKE AT "THE MAIN OUTER CYLINDER." THE CUSTOMER DID NOT REPORT ANY FOLLOW-UP CARE FOR BLOODBORNE EXPOSURE.

    Patient problems: Exposure to Body Fluids

    MAUDE report 24082066 ↗
  • MalfunctionJan 13, 2026Break

    IT WAS REPORTED THAT A SYRINGE BROKE "ABOUT A MONTH AGO." NO ADDITIONAL DETAILS ARE AVAILABLE RELATED TO THE CUSTOMER REPORTED ISSUE.

    Patient problems: Insufficient Information

    MAUDE report 24055307 ↗

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Sources and updates

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