CanadaOmni-Tract Surgical Retractor System (Integra LifeSciences Corporation), all lots, is affected and can be recognised by that product name. The manufacturer issued a correction because the Instructions for Use incorrectly specified a 30-minute prevacuum sterilization dry time; validated drying times are 90, 110, or 120 minutes and an updated IFU adds parameters for rigid containers. Contact the manufacturer for additional information.
What's being recalled
Companies: Integra Lifesciences Corporation, 4900 Charlemar Drive, Cincinnati, Ohio, United States, 45227.
How to identify it
Affected products: Omni-Tract Surgical Retractor System; Lot or serial number: All lots.; Model or catalogue number: Not applicable
The hazard
Integra Lifesciences is issuing a correction to the Integra® Omni-Tract® Surgical Retractor System - existing Instructions For Use (IFU) related to prevacuum sterilization dry time requirements, to ensure the Omni-Tract® devices and components are properly dried during sterilization to qualify current ISO standards. The current Omni-Tract® Surgical Retractor System IFU states a dry time of 30 minutes. The validated drying times utilizing standard pre-vacuum temperature and time standards were significantly longer and needed to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Update: Integra LifeSciences is issuing this additional updated correction to the Integra® Omni-Tract® Surgical Retractor System - Instructions for Use (IFU) adding prevacuum sterilization parameters when using a rigid container. Previously, in our June 2026 communication, Integra LifeSciences provided drying times solely for polypropylene wrapped sterilization trays informing you of three (3) the dry times (90 minutes, 110 minutes, or 120 minutes) depending on the sterilization cycle exposure time. This updated notification contains additional sterilization testing validated using a rigid container with the updated prevacuum sterilization cycle parameters.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)