Regard™ GS01143ARecalls & reported problems
Roi Cps, LLC · OPERATIVE LAP · Class 2
Data updated Oct 18, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Dec 18, 2023Class ITerminated
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
Z-0620-2024 · Root cause: Process control · Recall details · FDA record ↗
Other General Surgery Tray devices
- Halyard MSBM036-03_0012Avid Medical, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. DYNJ58534Medline Industries, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. DYNJ82007AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ42382BMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Medline Industries, Inc. DYNJ44866PMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNDL1350AMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ69692Medline Industries, Inc. · General surgery 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 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page