Official recall record
Omni-Tract Surgical Retractor System
- Issuing authority
- Health Canada
- Alert date
- 2026-08-11
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
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.
Record last checked against the registry on 2026-08-21.