Halyard 89601Recalls & reported problems
O&M Halyard, Inc. · SURGICAL MAYO STANDCOVER 54 · Class 2
- 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 10680651896015), received between Jan 24, 2025 and Jan 24, 2025 — classified as 1 malfunction.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 24, 2025
HALYARD MAYO STAND COVER WAS OPENED FOR PROCEDURE. WHEN PLACED ON MAYO STAND TO DRAPE, IT WAS FOUND BOTH ENDS OF THE DRAPE WERE OPEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229396 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.