Omni-Tract® 10707Recalls & reported problems
Integra Lifesciences Corporation · Omni-Tract® Omni-Access Sterile Field Post, 3/4in (1.9cm) Clamp with Universal Denver Maquet Jaw · Class 1
All models of Omni-Tract (447)
Data updated Oct 18, 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 10381780271512), received between Feb 19, 2026 and Feb 19, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Unstable” (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 18, 2026.
Reports received per month
Recalls naming this device
- Jun 5, 2026Class IIOpen, 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
- Unstable1
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.
MalfunctionFeb 19, 2026Unstable
A FACILITY REPORTED THAT DURING AN ABDOMINAL AORTIC ANEURYSM PROCEDURE, THE OMNI-ACCESS STERILE FIELD POST (10707) WISHBONE FRAME DID NOT ATTACH OR LOCK TO THE FIELD POST CORRECTLY DURING THE SURGERY. THE PATIENT WAS PREPPED, AND UNDER ANESTHESIA, AND THE MALFUNCTION RESULTED IN A 30-MINUTE SURGICAL DELAY. THERE WAS NO INJURY OR DEATH REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24397347 ↗
Other RETRACTOR, NON-SELF-RETAINING devices
- Omni-Tract® 4080Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall1 report
- Omni-Tract® 3092Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 4963Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3804RIntegra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3132RIntegra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3536Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 4604Integra Lifesciences Corporation · RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 4921Integra 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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