Halyard 69195Recalls & reported problems
O&M Halyard, Inc. · HALYARD* X-TRA TRACTION* Shoe Cover, XL, Blue · Class 1
Data updated Oct 16, 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 20680651691952), received between Dec 22, 2017 and Dec 22, 2017 — classified as 1 injury.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
- Device Operates Differently Than Expected1
Patient problems
- Fall1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 22, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED BY THE CUSTOMER WHO STATED, "THERE HAS BEEN A MAJOR EMPLOYEE INJURY HERE AT THE HOSPITAL WITHIN THE LAST FEW DAYS." THE WAS NO TRACTION AT THE BOTTOM OF THE SHOW COVER AND THE EMPLOYEE SLIPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY NOT RECEIVED.
Patient problems: Fall
MAUDE report 7141510 ↗
Other COVER, SHOE, OPERATING-ROOM devices
- Halyard 69252O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM26 reports
- Halyard 69254O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM11 reports
- Halyard 69353O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM6 reports
- Regard™ CVRBTTIEXL-REGResource Optimization & Innovation, L.L.C. · Cover, Shoe, Operating-Room1 report
- Regard™ CVRBTTIEL-REGResource Optimization & Innovation, L.L.C. · Cover, Shoe, Operating-Room1 report
- CARDINAL HEALTH 4850Cardinal Health 200, LLC · COVER, SHOE, OPERATING-ROOM1 report
- CARDINAL HEALTH 2854Cardinal Health 200, LLC · COVER, SHOE, OPERATING-ROOM1 report
- CARDINAL HEALTH 4854Cardinal Health 200, LLC · COVER, SHOE, OPERATING-ROOM1 report
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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