CARDINAL HEALTH 2854Recalls & reported problems
Cardinal Health 200, LLC · SHOECOVER ANTI-SKID · Class 1
Data updated Oct 18, 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 20885380018357), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 injury.
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 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
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.
InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A STAFF MEMBER FELL AND WAS INJURED WHILE WEARING THE SHOE COVERS. THEY BELIEVE IT IS BECAUSE OF THE SHOE COVERS NOT HAVING ANY TREAD ON THEM.
Patient problems: Fall
MAUDE report 8452503 ↗
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™ CVRBTTIEL-REGResource Optimization & Innovation, L.L.C. · Cover, Shoe, Operating-Room1 report
- Halyard 69195O&M Halyard, Inc. · COVER, SHOE, OPERATING-ROOM1 report
- CARDINAL HEALTH 4850Cardinal Health 200, LLC · COVER, SHOE, OPERATING-ROOM1 report
- CARDINAL HEALTH 4854Cardinal 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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