Regard™ NU00974FRecalls & reported problems
Roi Cps, LLC · SPINE HC · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Oct 20, 2022Terminated
Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled.
Z-0302-2023 · Root cause: Component change control · FDA record ↗
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- Medline Industries, Inc. CDS981327QMedline Industries, Inc. · Neurological tray4 recalls0 reports
- Medline Industries, Inc. DYNJ21925SMedline Industries, Inc. · Neurological tray4 recalls0 reports
- Medline Industries, Inc. DYNJ53799Medline Industries, Inc. · Neurological tray4 recalls0 reports
- Medline Industries, Inc. DYNJ60792CMedline Industries, Inc. · Neurological tray4 recalls0 reports
- Medline Industries, Inc. DYNJ58704AMedline Industries, Inc. · Neurological tray4 recalls0 reports
- Medline Industries, Inc. DYNJ909744Medline Industries, Inc. · Neurological tray4 recalls0 reports
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 13, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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