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Medline Industries, Inc. DYNJ89754Recalls & reported problems

Medline Industries, Inc. · OH CORONARY FEMORAL PACK · Class 2

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

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10198459289798), received between Nov 24, 2025 and Sep 14, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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: 2 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: 1 reportsSep 2026: 1 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Break1
  • Contamination1
  • Crack1
  • Insufficient Device Problem Information1
  • Sharp Edges1

Patient problems

  • No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 14, 2026Break

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50765008 ↗
  • MalfunctionAug 11, 2026Contamination; Insufficient Device Problem Information

    It was reported that "linting OR towels and gauze in both packs."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50208891 ↗
  • MalfunctionNov 26, 2025Crack; Sharp Edges; Crack; Sharp Edges

    A SYRINGE WAS FOUND WITH ONE WING CRACKED AND HAD SHARP EDGES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23660710 ↗
  • MalfunctionNov 24, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE SYRINGES "AREN'T DRAWING UP PROPERLY".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23640465 ↗

Other Cardiovascular procedure kit devices

All Cardiovascular procedure kit devices →

Sources and updates

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