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Steri-Drape™ 1013Recalls & reported problems

3m Company · 3M™ Steri-Drape™ X-Ray Image Intensifier Drape, 10 per Carton / 4 Cartons per Case, 1013 · Class 2

All models of Steri-Drape (11)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30707387020911), received between Mar 22, 2019 and Mar 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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 16, 2026.

Most reported problems

Device problems

  • Material Split, Cut or Torn1
  • Melted1
  • Physical Resistance/Sticking1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionMar 22, 2019Melted; Material Split, Cut or Torn; Physical Resistance/Sticking

    STERILE BARRIER ISSUE WITH C-ARM DRAPES X 2 W/ SAME LOT NUMBER. THE FIRST DRAPE SEEMED TO BE MELTED & STUCK TOGETHER; 2ND DRAPE WAS SPLIT OPEN, NOT INTACT.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8443241 ↗

Other Drape, surgical, exempt devices

All Drape, surgical, exempt devices →

Sources and updates

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