Public recall detail

Omni-Tract Surgical Retractor System

2026-07-03

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Health products Health product recall
Quick summary

Quick summary: Omni-Tract Surgical Retractor System. Reason: Health product recall. Category: Health products. Date: 2026-07-03.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: Omni-Tract Surgical Retractor System. Reason: Health product recall. Category: Health products. Date: 2026-07-03.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandIntegra Lifesciences Corporation
ProductOmni-Tract Surgical Retractor System
IssueMedical devices - Sterility
Recall classType II
IdentificationRA-82277

Affected products

ProductOmni-Tract Surgical Retractor System
LotAll lots.
ModelNot applicable
Serial numberAll lots.
DescriptionOmni-Tract Surgical Retractor System

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare Industry
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesIntegra Lifesciences Corporation4900 Charlemar Drive, Cincinnati, Ohio, United States, 45227
Recall date2026-06-24
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82277
Background{}
CompaniesIntegra Lifesciences Corporation4900 Charlemar Drive, Cincinnati, Ohio, United States, 45227
AudiencesHealthcare Industry
Source updated2026-07-03

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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