Halyard 79758Recalls & reported problems
O&M Halyard, Inc. · HYH,ARTHRO,SHLDR,-,-,50 · Class 2
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 30680651797583), received between Feb 2, 2026 and Feb 2, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Disintegration” (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.
Reports received per month
Most reported problems
Device problems
- Material Disintegration1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 2, 2026Material Disintegration
CONCERNS HAVE BEEN RAISED REGARDING THE QUALITY OF THE DRAPES, AS THEY HAVE BEEN OBSERVED TO DETERIORATE DURING USE, RESULTING IN FRAGMENTS ENTERING OPEN SHOULDER WOUNDS. THE COMPLAINANT HAS INDICATED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PATIENT INJURY.
Patient problems: Insufficient Information
MAUDE report 24234235 ↗
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- Medline DYNJP2416Medline Industries, Inc. · Drape, surgical2 recalls1 report
- Medline DYNJP4003Medline Industries, Inc. · Drape, surgical2 recalls0 reports
- Medline DYNJP2418Medline Industries, Inc. · Drape, surgical2 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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