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Omni-tract surgical retractor system
Official notice
3 Jul 2026
Last checked
3 Jul 2026
An official Health Canada notice concerns Omni-tract surgical retractor system. 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. Published 2026-07-03.
What to do now
Contact the manufacturer if you require additional information.
Recall number
82277
Official notice
2026-07-03
The hazard
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.
How to check if you're affected
How to check if you're affected
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Brand: Integra Lifesciences.
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Documents, notices & source
See the official notice and source documents for full details.
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