Halyard 48094Recalls & reported problems
O&M Halyard, Inc. · ORTHOARTS Lower Drape · 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 10680651480948), received between Jul 5, 2023 and Jul 5, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
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.
MalfunctionJul 5, 2023Fluid/Blood Leak; Fluid/Blood Leak
A MAUDE ADVERSE EVENT REPORT 15515323 WAS FOUND WHEN PERFORMING MAUDE SEARCH FOR POSTMARKET SURVEILLANCE REPORT PREPARATION. SEARCH OF THE COMPLAINT DATABASE, DID NOT FIND THAT A PRIOR COMPLAINT WAS RECEIVED FOR THIS INCIDENT. AT THE END OF THE SURGICAL CASE WHEN REMOVING THE DRAPES OFF OF THE PATIENT, THE SURGEON NOTICED THAT THE LOWER EXTREMITY DRAPE WAS TORN UNDER THE PATIENT'S KNEE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17261520 ↗
Other Drape, surgical, exempt devices
- Medline DYNJP3102AMedline Industries, Inc. · Drape, surgical, exempt3 recalls2 reports
- Medline DYNJP2498Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls1 report
- Medline DYNJP8005UGMedline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP3103Medline Industries, Inc. · Drape, Surgical, Exempt3 recalls0 reports
- Medline DYNJP8304AMedline Industries, Inc. · Drape, surgical, exempt3 recalls0 reports
- Medline DYNJP9103Medline Industries, Inc. · Drape, surgical, exempt2 recalls7 reports
- Medline DYNJP8201Medline Industries, Inc. · Drape, surgical, exempt2 recalls6 reports
- Medline DYNJP6006Medline Industries, Inc. · Drape, surgical, exempt2 recalls4 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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