Regard™ GS00367GRecalls & reported problems
Roi Cps, LLC · Class 2
Data updated Oct 16, 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 16, 2026.
Recalls naming this device
- May 3, 2022Terminated
Potential for the tip of the electrode to detach during use.
Z-1250-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Other Laparoscopy Kit devices
- Medline Industries, Inc. DYNJ82871Medline Industries, Inc. · laparoscopy kit5 recalls0 reports
- Medline Industries, Inc. DYNJ52656BMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ905071FMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. CDS860015WMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. CDS860016RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ21927RMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ0426069NMedline Industries, Inc. · laparoscopy kit4 recalls0 reports
- Medline Industries, Inc. DYNJ58561DMedline Industries, Inc. · laparoscopy kit3 recalls1 report
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 16, 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