OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

What happened?

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 should I do now?

1Check the lot number on your product packaging.
2If you have it, stop using it.
3Return it to your pharmacy or store for a refund.
4If you already used it and feel unwell, see your doctor immediately.
5Report adverse effects to the FDA: 1-800-FDA-1088.

Company: Integra LifeSciences Corp. (NeuroSciences)
Status: Ongoing
Report date: 2026-07-15
Initiated: 2026-06-05
Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea (the Republic of), Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands (the), New Zealand, Norway, Pakistan, Palestine, State of, Philippines (the), Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, R¿union, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Thailand, Trinidad and Tobago, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland, (the), Viet Nam.
Quantity: 633 units

This is NOT medical advice. Consult with your pharmacist or doctor before making decisions.