Regard™ NU00096AJRecalls & reported problems
Roi Cps, LLC · NEURO · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10194717114024), received between Mar 6, 2023 and Mar 11, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available3
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Insufficient Information3
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
TEAR NOTED IN VENTED BAG WHEN SETTING UP FOR CASE.
Patient problems: Insufficient Information
MAUDE report 18873719 ↗MalfunctionMar 8, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
MalfunctionApr 12, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
DAMAGED PACKS IDENTIFIED WHILE SETTING UP FOR CASE. DAMAGE WAS TO THE VENTED BAG. DAMAGED KITS WERE REMOVED AND A NEW KIT OPENED FOR CASE. NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16727897 ↗MalfunctionMar 6, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
CUSTOM PACKS WERE DISCOVERED WITH CUTS IN THEM, CAUSING CONTAMINATION OF PACK. CUSTOMER INDICATED THAT THERE WERE POTENTIALLY 3 LOTS. PACKS WERE DISCARDED AND NEW PACKS WERE PULLED FROM STERILE SUPPLY. CUSTOMER DID NOT PROVIDE PICTURES OR RETURN SAMPLES FOR INVESTIGATION. THERE WAS NO PATIENT CONTACT.
Patient problems: Insufficient Information
MAUDE report 16491717 ↗
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- 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
- Medline Industries, Inc. DYNJ21925SMedline Industries, Inc. · Neurological tray4 recalls0 reports
- Medline Industries, Inc. DYNJ53799Medline Industries, Inc. · Neurological tray4 recalls0 reports
- Medline Industries, Inc. DYNJ40040CMedline 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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