Omni-Tract Surgical Retractor System Recall

Source: Health Canada · Canada

Areazine synthesizes this Health Canada recall directly from Health Canada's official public data feed. See our methodology for full source attribution and refresh cadence.

Integra Lifesciences is correcting the Instructions For Use for the Omni-Tract Surgical Retractor System to update prevacuum sterilization dry times.

What this Health Canada recall tells you, and what most readers miss

This notice was issued by Health Canada on August 1, 2026 and geographically references Canada. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - Product & Food Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, health-canada, surgical-instrument.

What Happened

Integra Lifesciences Corporation is issuing a correction to the Integra® Omni-Tract® Surgical Retractor System Instructions For Use (IFU) related to prevacuum sterilization dry time requirements. The current IFU states a dry time of 30 minutes, but validated drying times are 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used, to ensure devices and components are properly dried and qualify current ISO standards.

Which Products Are Affected

Omni-Tract Surgical Retractor System. All lots. Model or catalogue number: Not applicable.

What You Should Do

No specific consumer action is provided in the recall notice.

Why This Matters

The correction ensures the Omni-Tract devices and components meet ISO standards for proper drying during sterilization.

Source

Health Canada

Original source: Health Canada Official Notice ↗

All Product & Food Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this Health Canada recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this Health Canada recall.

What is this Health Canada recall about?
Integra Lifesciences is correcting the Instructions For Use for the Omni-Tract Surgical Retractor System to update prevacuum sterilization dry times.
Which agency issued this alert?
This alert was issued by Health Canada. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Canada. Check with Health Canada for the most current geographic scope.
Where can I find more Product & Food Recalls updates?
Browse the full Product & Food Recalls feed on Areazine at areazine.com/ca/recalls/ for the latest updates from Health Canada and other agencies.