Recall Z-2714-2026 ยท GAD Retractor
Integra LifeSciences Corp. (NeuroSciences)
OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.
| Date | Jul 9, 2026 (initiated Jun 5, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling design |
| Action | Integra issued an URGENT: VOLUNTARY MEDICAL DEVICE CORRECTION notice to its consignees on 06/05/2026 via overnight mail. The notice explained the issue, hazards and risks, and requested the following: "Customer/Medical Facility-Actions to Take: 1. If your facility has validated its own sterilization process, it is in your discretion to follow your validated process recognizing that Integra LifeSciences has only validated the sterilization process noted below. 2. If utilizing the Gravity Sterilization Method, stop using this method immediately. The Gravity Sterilization Method for sterilizin |
| Quantity | 633 units |
| 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, Japan, J |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.