Regard™ GS01036BRecalls & reported problems
Roi Cps, LLC · UNIVERSAL CUSTOM · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10194717112389), received between Jun 1, 2023 and Jun 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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
- Mar 22, 2023Open, Classified
The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.
Z-1432-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Manufacturing, Packaging or Shipping Problem1
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.
MalfunctionJun 1, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
TEARS NOTED IN BOTH THE VENTED BAG AND BACK TABLE COVER BEFORE OPENING PACK FOR USE. PACK WAS REMOVED AND A NEW PACK WAS OPENED FOR CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17039812 ↗
Other General Surgery Tray devices
- Medline Industries, Inc. DYNJ58534Medline Industries, Inc. · General surgery tray5 recalls0 reports
- Halyard MSBM036-03_0012Avid Medical, Inc. · General surgery tray5 recalls0 reports
- Medline Industries, Inc. ACC010690Medline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ0842793FMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ38333DMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Centurion ART690Centurion Medical Products Corporation · General Surgery Tray4 recalls0 reports
- Medline Industries, Inc. DYNJ50110BMedline Industries, Inc. · General surgery tray4 recalls0 reports
- Medline Industries, Inc. DYNJ908124AMedline 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 · each report above links to its original FDA record
- 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