Regard™ GS00264FRecalls & reported problems
Roi Cps, LLC · 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
- Nov 20, 2023Terminated
ROi CPS manufactured and distributed medical convenience kits with an irrigation solution component which was subsequently recalled by the component manufacturer.
Z-0596-2024 · Root cause: Nonconforming Material/Component · FDA record ↗
Other Dressing Change Tray devices
- MEDLINE EBSI1382Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DT8670ACenturion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion Medical Products Corp DT22065Medline Industries, Inc. · Dressing change tray2 recalls0 reports
- MEDLINE CVI4770AMedline Industries, Inc. · Dressing change tray2 recalls0 reports
- Centurion DT18700Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion DM1035ACenturion Medical Products Corporation · Dressing change tray2 recalls0 reports
- Centurion DM1035Centurion Medical Products Corporation · Dressing change tray2 recalls0 reports
- MEDLINE EBSI1498Medline Industries, Inc. · Dressing change tray2 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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