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Health Canada3 Jul 2026

Omni-Tract Surgical Retractor System

Health Canada published a recall notice for Omni-Tract Surgical Retractor System on 3 Jul 2026. It is one of 311 notices of this kind from Health Canada since 2 Apr 2026 in AreaZine's record.

Recall

The recall notice

Issued by
Health Canada
Issued
3 Jul 2026
Recall type
Health product recall
Companies
Integra Lifesciences Corporation4900 Charlemar Drive, Cincinnati, Ohio, United States, 45227
Official source
Health Canada: the notice at its source

The latest from Health CanadaEvery warning and recall in Canada

Source: Health Canada: the notice at its source. AreaZine rebuilds this page from the agency's record; the agency's page is the one to act on. Contains information licensed under the Open Government Licence – Canada.

The notice as issued

Issue: 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. Additional information Details Original published date: 2026-07-03 Affected products: Affected products Lot or serial number Model or catalogue number Omni-Tract Surgical Retractor System All lots. Not applicable Issue

Source: Health Canada: the notice at its source. The text is the agency's, unedited. Contains information licensed under the Open Government Licence – Canada.

The record around this notice