Omni-Tract® 11275Recalls & reported problems
Integra Lifesciences Corporation · Omni-Tract® Speed-Tract®, 1in x 1in (2.5cm x 2.5cm) Coupler · 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10381780271604), received between Oct 2, 2024 and Oct 7, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Corroded” (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
- Corroded1
- Problem with Sterilization1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 7, 2024
NEW INTEGRA INSTRUMENTS ARRIVED WITH RUST. THESE ARE NEW INSTRUMENTS IN THE PACKAGE CURRENTLY UN-STERILE BUT INTENDED FOR STERILIZATION. UPON OPENING THE PACKAGE THERE WAS A LOT OF VISIBLE RUST PRESENT ON THE INSTRUMENTS. THIS IS THE SECOND ORDER OF INSTRUMENTS THAT HAVE ARRIVED IN THIS CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384439 ↗MalfunctionOct 2, 2024Corroded; Problem with Sterilization
NEW INTEGRA INSTRUMENTS ARRIVED WITH RUST. THESE ARE NEW INSTRUMENTS IN THE PACKAGE CURRENTLY NON-STERILE BUT INTENDED FOR STERILIZATION. UPON OPENING THE PACKAGING THERE WAS A LOT OF VISIBLE RUST PRESENT ON THE INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20350518 ↗
Other RETRACTOR devices
- Endo Paddle Retract 173046Covidien LP · RETRACTOR56 reports
- Omni-Tract® 4040Integra Lifesciences Corporation · RETRACTOR1 recall3 reports
- RadiaLux™ 50-101-1Medtronic Navigation, Inc. · RETRACTOR1 recall2 reports
- CHARNLEY 9620-04-000Depuy International Ltd · RETRACTOR1 recall2 reports
- NA 2176-10-000Depuy (Ireland) · RETRACTOR51 reports
- Fathom MR2-102050Seaspine Orthopedics Corporation · RETRACTOR1 recall1 report
- Omni-Tract® 11303RIntegra Lifesciences Corporation · RETRACTOR1 recall0 reports
- Omni-Tract® 11445Integra Lifesciences Corporation · RETRACTOR1 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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