Omni-TractRecalls & reported problems across all models
Integra Lifesciences Corporation · 447 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Omni-Tract model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 447 models of Omni-Tract by Integra Lifesciences Corporation in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between Oct 2, 2024 and Feb 19, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
1 FDA recall record name at least one of these models by its device 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Omni-Tract recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · names 447 of these models · Recall details · FDA record ↗
Most reported Omni-Tract problems
Device problems
- Break2
- Corroded1
- Mechanical Problem1
- Mechanics Altered1
- Problem with Sterilization1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
Omni-Tract models
447 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Omni-Tract® 4040RETRACTOR1 recall3 reports
- Omni-Tract® 11275RETRACTOR1 recall2 reports
- Omni-Tract® 4080RETRACTOR, NON-SELF-RETAINING1 recall1 report
- Omni-Tract® 10707RETRACTOR, NON-SELF-RETAINING1 recall1 report
- Omni-Tract® 4950RETRACTOR1 recall0 reports
- Omni-Tract® 10272RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 11182RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 11183RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3030RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3032RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3041RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3046RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3053RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3055RETRACTOR1 recall0 reports
- Omni-Tract® 3069RETRACTOR1 recall0 reports
- Omni-Tract® 3076RETRACTOR1 recall0 reports
- Omni-Tract® 3086RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3091RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3092RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3093RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3094RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3096RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3098RETRACTOR1 recall0 reports
- Omni-Tract® 3099RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3101RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3103RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3104RRETRACTOR1 recall0 reports
- Omni-Tract® 3105RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3120RRETRACTOR1 recall0 reports
- Omni-Tract® 3121RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3132RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3133RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3137RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3138RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3142RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3145RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3146RETRACTOR1 recall0 reports
- Omni-Tract® 3147RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3148RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3150RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3151RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3152RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3167RRETRACTOR1 recall0 reports
- Omni-Tract® 3169RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3175RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3176RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3177RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3178RRETRACTOR1 recall0 reports
- Omni-Tract® 3185RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3187RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3201RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3203RETRACTOR1 recall0 reports
- Omni-Tract® 3216RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3217RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3218RETRACTOR1 recall0 reports
- Omni-Tract® 3219RETRACTOR1 recall0 reports
- Omni-Tract® 3220RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3222RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3223RRETRACTOR1 recall0 reports
- Omni-Tract® 3225RRETRACTOR1 recall0 reports
- Omni-Tract® 3259RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3265RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3274RETRACTOR1 recall0 reports
- Omni-Tract® 3279RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3281RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3311RRETRACTOR1 recall0 reports
- Omni-Tract® 3312RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3335RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3336RETRACTOR1 recall0 reports
- Omni-Tract® 3341RRETRACTOR1 recall0 reports
- Omni-Tract® 3342RETRACTOR1 recall0 reports
- Omni-Tract® 3343RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3361RRETRACTOR1 recall0 reports
- Omni-Tract® 3373RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3374RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3375RRETRACTOR1 recall0 reports
- Omni-Tract® 3376RRETRACTOR1 recall0 reports
- Omni-Tract® 3377RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3379RRETRACTOR1 recall0 reports
- Omni-Tract® 3391RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3392RRETRACTOR1 recall0 reports
- Omni-Tract® 3393RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3394RRETRACTOR1 recall0 reports
- Omni-Tract® 3397RRETRACTOR1 recall0 reports
- Omni-Tract® 3398RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3399RRETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3422RRETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3424RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3426RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3483RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3485RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3529RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3530RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3531RETRACTOR, SELF-RETAINING1 recall0 reports
- Omni-Tract® 3532RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3533RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3534RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3535RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3536RETRACTOR, NON-SELF-RETAINING1 recall0 reports
- Omni-Tract® 3537RETRACTOR1 recall0 reports
Recent Omni-Tract adverse event reports
The 7 most recent reports across all models, 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 ↗MalfunctionFeb 5, 2026Break
A FACILITY REPORTED THAT DURING A SURGICAL PROCEDURE, THE SNAP CLAMP ASSEMBLY (4040) EXHIBITED A DEFECT, WHICH WAS A TIGHTENING PROBLEM ON THE HOOP THAT RESULTED IN A 30-MINUTE DELAY IN SURGICAL TIME. ANOTHER SURGICAL INSTRUMENT WAS USED TO COMPLETE THE SURGERY. NO PATIENT INJURIES OR DEATHS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24267958 ↗MalfunctionJul 1, 2025Mechanical Problem; Mechanical Problem
A FACILITY ENGINEER REPORTED THAT THE CLAMPING FORCE OF THE SNAP CLAMP ASSEMBLY (4040) ON THE RETRACTOR ROD WAS "TOO LOW, THAT THE CLAMP YIELDS TO TISSUE PRESSURE." THERE WAS NO PATIENT INJURY; HOWEVER, A SURGICAL DELAY EXCEEDING 30 MINUTES WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22375287 ↗MalfunctionMar 5, 2025Break; Break
A FACILITY REPORTED THAT DURING A "HIGHLY COMPLEX DIGESTIVE SURGERY INVOLVING A PANCREATICODUODENECTOMY WITH VASCULAR RESECTION", THE SNAP CLAMP ASSEMBLY (4040) "SPONTANEOUSLY BROKE WHILE BEING MANIPULATED." THE BROKEN RETRACTOR DID NOT FALL INTO THE SURGICAL SITE, AND ALL BROKEN PARTS WERE SUCCESSFULLY RECOVERED. THERE WAS NO INJURY TO THE PATIENT; HOWEVER, A SURGICAL DELAY OF TWO HOURS WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21532619 ↗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 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 ↗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 Integra Lifesciences Corporation products
All Integra Lifesciences Corporation devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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