Omni-Tract® 4080Recalls & reported problems
Integra Lifesciences Corporation · Omni-Tract® FastSystem® Sterile Field Post · Class 1
All models of Omni-Tract (447)
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 10381780270652), received between Oct 4, 2024 and Oct 4, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanics Altered” (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.
Reports received per month
Recalls naming this device
- Jun 5, 2026Open, Classified
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Z-2714-2026 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- Mechanics Altered1
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.
MalfunctionOct 4, 2024Mechanics Altered; Mechanics Altered
IT WAS REPORTED THAT THE FASTSYSTEM STERILE FIELD POST (4080) DID NOT STAY TIGHTENED WHEN ATTACHED TO THE TABLE DURING SURGERY. A DELAY OF AT LEAST 30 MINUTES WAS REPORTED AS A RESULT OF LOOKING FOR ANOTHER RETRACTOR USED TO COMPLETE THE SURGERY. THE WAS NO PATIENT INJURY OR DEATH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20370720 ↗
Other RETRACTOR, NON-SELF-RETAINING devices
- Omni-Tract® 10707Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall1 report
- Omni-Tract® 3133Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 11629Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 4090Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 4615RIntegra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 11640Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3220Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3529Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 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.
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