Recall Z-2714-2026— Integra LifeSciences Corp. (NeuroSciences)
Class II · Ongoing
Class II FDA medical device recall by Integra LifeSciences Corp. (NeuroSciences), initiated 2026-06-05. Product: OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.. Reason: 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..
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-06-05
- Firm location
- Princeton, NJ, United States
Product description
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.