Integra® Jarit® 625164Recalls & reported problems
Integra Lifesciences Production Corporation · Integra® Jarit® Hunter Bowel Grasper, 15", Roto-Lok™, double action, insulated, 5mm · Class 2
All models of Integra Jarit (57)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780147343), received between May 3, 2024 and May 3, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Biofilm coating in Device” (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
- Biofilm coating in Device1
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.
MalfunctionMay 3, 2024Biofilm coating in Device; Biofilm coating in Device
IT WAS REPORTED THAT UPON INSPECTING THE ROTO-LOK HUNTER BOWEL/LL 37CM (625164LL), A SIGNIFICANT AMOUNT OF BIOBURDEN WAS STILL STUCK IN THE JAWS. IT WAS REPORTED THAT THE INSTRUMENT WAS A CONSIGNMENT REQUEST AND WAS NOT USED IN A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19244003 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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