Regard™ OR00922DRecalls & reported problems
Roi Cps, LLC · MAJOR EXTREMITY · Class 1
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 10194717115816), received between Oct 29, 2024 and Oct 29, 2024 — classified as 1 malfunction.
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
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
THE ORANGE LAMINATED # 2 WAS FOUND INSIDE THE PACK BETWEEN THE SPLIT DRAPES. THE TECH DID NOT REALIZE UNTIL THEY WERE DRAPING THE PATIENT. THE ENTIRE SURGICAL SETUP HAD TO BE BROKEN DOWN PRIOR TO STARTING THE SURGERY. THIS CAUSED A CASE DELAY WITH PATIENT ASLEEP ON THE TABLE. THE # 2 HAS OLD TAPE ON IT ALMOST LIKE IT CAME FROM A WORKSTATION IN A FACTORY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 20557853 ↗
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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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