OmniTract Surgical Retractor System sterilization instructions require extended dry time
Integra LifeSciences is recalling the OmniTract Surgical Retractor System because the sterilization instructions require a longer dry time than stated in the current manual. The dry time must be extended to 90, 110, or 120 minutes depending on the sterilization cycle used.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an instructional defect—specifically, incorrect sterilization parameters in the device manual. No illnesses or injuries have been reported, and the hazard is correctable through updated instructions. This meets the criteria for a Moderate severity rating.
Plain-English summary
Integra LifeSciences Corp. is recalling the OmniTract Surgical Retractor System, which includes 633 product codes. The current instructions for use state a dry time of 30 minutes, but the company has determined that the dry time must be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
The affected product is distributed worldwide, including throughout the United States and Australia, Austria, Azerbaijan, Bangladesh, Belgium, Brunei Darussalam, Bulgaria, Canada, Chile, China, Czechia, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands, New Zealand, Norway, Pakistan, Palestine, Philippines, Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, Réunion, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Healthcare facilities and users of the OmniTract Surgical Retractor System should refer to updated sterilization instructions for the correct dry time appropriate to their sterilization cycle. Contact Integra LifeSciences for clarification on the extended dry times and updated instructions for use.
The recalled product
- Product
- OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Hazard
- sterilization-instruction-error
- inadequate-drying-time
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Product Code 3032
- UDI 10381780268468
- Product Code 3055
- UDI 10381780268505
- Product Code 3069
- UDI 10381780268512
- Product Code 3076
- UDI 10381780268529
- Product Code 3086
- UDI 10381780268536
- Product Code 3092
- UDI 10381780268550
- Product Code 3093
- UDI 10381780268567
- Product Code 3096
- UDI 10381780268581
- Product Code 3098
- UDI 10381780268598
- Product Code 3099
- UDI 10381780268604
Distribution
Distributed nationwide across the United States.
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