Official recall record
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-06-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 10381780268468
- Brand on record
- Integra LifeSciences Corp. (NeuroSciences)
- Product category
- Medical Device
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.
Record last checked against the registry on 2026-09-16.
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