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MEDLINE INDUSTRIES, INC. DYNJT5308Recalls & reported problems

Medline Industries, Inc. · SHOULDER ARTHROSCOPY SAH · Class 2

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

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 10198459471810), received between May 15, 2026 and May 15, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Adhesive Too Strong” (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: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 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

  • Adhesive Too Strong1

Patient problems

  • Skin Tears1

Recent adverse event reports

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

  • InjuryMay 15, 2026Adhesive Too Strong

    ACCORDING TO THE CUSTOMER, ON (B)(6) 2026 TWO SKIN TEARS FROM THE DRAPE WERE NOTED ON THE "RIGHT PEC, ABOVE THE NIPPLE" FOLLOWING A "SHOULDER ARTHROSCOPY." PER THE FACILITY, "THEY CAME TO THE CONCLUSION THAT IT'S USER ERROR AS NO OTHER LOCATION IS REPORTING PROBLEMS WITH [THE] DRAPE."

    Patient problems: Skin Tears

    MAUDE report 25193436 ↗

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Sources and updates

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