JustRight Sealer JR-SE20Recalls & reported problems
Justright Surgical, LLC · JustRight Sealer - single · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00865163000126), received between Apr 9, 2021 and Apr 29, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).
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.
Most reported problems
Device problems
- Loss of or Failure to Bond2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2021Loss of or Failure to Bond
DEVICE STOPPED WORKING. DID NOT SEAL TISSUE. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, JUST RIGHT SEALER (PER SITE REPORTER).
Patient problems: Insufficient Information
MAUDE report 11744467 ↗MalfunctionApr 9, 2021Loss of or Failure to Bond
DEVICE STOPPED WORKING, STOPPED SEALING TISSUE. MANUFACTURER RESPONSE FOR ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES, JUST RIGHT SEALER (PER SITE REPORTER).
Patient problems: Insufficient Information
MAUDE report 11640694 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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