Halyard 69353Recalls & reported problems
O&M Halyard, Inc. · HALYARD* ANKLE GUARD* Shoe Cover, X-Large · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20680651693536), received between Aug 12, 2026 and Aug 13, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (6 reports).
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
- Device Unsafe to Use in Environment6
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Device Unsafe to Use in Environment
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230402 ↗InjuryAug 13, 2026Device Unsafe to Use in Environment
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50230401 ↗InjuryAug 12, 2026Device Unsafe to Use in Environment
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50223008 ↗InjuryAug 12, 2026Device Unsafe to Use in Environment
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222981 ↗InjuryAug 12, 2026Device Unsafe to Use in Environment
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222964 ↗InjuryAug 12, 2026Device Unsafe to Use in Environment
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222958 ↗
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
- Regard™ CVRBTTIEXL-REGResource Optimization & Innovation, L.L.C. · Cover, Shoe, Operating-Room1 report
- Halyard 69195O&M Halyard, Inc. · 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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