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Regard™ OR00353LRecalls & reported problems

Roi Cps, LLC · 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 10194717106654), received between Oct 12, 2021 and Oct 12, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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

  • Material Split, Cut or Torn1

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.

  • MalfunctionOct 12, 2021Material Split, Cut or Torn

    TEARS/CUTS IN VENTED BAG WAS IDENTIFIED PRIOR TO THE KIT BEING BROUGHT INTO THE OPERATING ROOM. NO PATIENT CONTACT, NO HARM TO PATIENT AND NO DELAY TO CASE. PACK WAS DISCARDED AND A NEW ONE PULLED FROM INVENTORY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12618748 ↗

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Sources and updates

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