Recall record at a glance
| Official record | Z-2714-2026 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Ongoing |
| Recalling firm | Integra LifeSciences Corp. (NeuroSciences) |
| Report date | Jul 15, 2026 |
| Recall initiation date | Jun 5, 2026 |
| Quantity | 633 units |
| Location | Princeton, NJ, United States |
Official product description
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
Why the product was recalled
The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.
Distribution information
Worldwide distribution - US Nationwide and the countries of 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 (the Republic of), Kuwait, Lithuania, Malaysia, Malta, Mauritius, Mexico, Nepal, Netherlands (the), New Zealand, Norway, Pakistan, Palestine, State of, Philippines (the), Poland, Portugal, Puerto Rico, Qatar, Republic of North Macedonia, R¿union, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan (Province of China), Thailand, Trinidad and Tobago, Turkey, United Arab Emirates (the), United Kingdom of Great Britain and Northern Ireland, (the), Viet Nam.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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