Integra Lifesciences Corp. (neurosciences): Retractor
Recall Summary Integra LifeSciences is recalling the OmniTract Surgical Retractor System (633 product codes) because the instructions provided to hospitals and surgical centers state an incorrect drying time of 30 minutes, when the actual required drying time is 90 to 120 minutes depending on the sterilization method used. This product has been distributed worldwide, including throughout the United States and 50+ other countries. This is classified as a Class I recall, the most serious category.
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- Product
- OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-05
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1c6e3137-ccff-45dc-ab83-228e52d03bc3