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Omni-Tract® 3030RRecalls & reported problems

Integra Lifesciences Corporation · Omni-Tract® Post Assembly, Double Joint · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. 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 · FDA record ↗

Other RETRACTOR, SELF-RETAINING devices

All RETRACTOR, SELF-RETAINING devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.