Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36946 |
| Brand Name: | Retractor Components |
| Model: | Integra Omni-Tract Surgical Retractor System |
| Affected: | All lot numbers |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Brand Name: | Omni-Tract Radiolucent |
| Model: | Integra Omni-Tract Surgical Retractor System |
| Affected: | All lot numbers |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Brand Name: | Omni-Tract Obesity Blades |
| Model: | Integra Omni-Tract Surgical Retractor System |
| Affected: | All lot numbers |
| Software version: | |
| Recalling Organisation: | Integra Neurosciences Pty Ltd (NZ) 12 Florence Avenue Orewa Auckland 0931 |
| Contact Information: | 0800 400 660 |
| Manufacturer: | Integra LifeSciences Corporation |
| Issue: | An Instructions for Use (IFU) update has been issued for the Omni-Tract Surgical Retractor System to update validated steam sterilisation parameters and approved configurations. The previous IFU specified a 30-minute drying time; however, validation has confirmed that longer drying times (90–120 minutes depending on cycle exposure) are required to ensure adequate drying in pre-vacuum steam sterilisation cycles. The correction also removes rigid container use and gravity displacement sterilisation as approved methods, as these configurations have not been validated. This update is to ensure compliance with applicable ISO standards and to reduce the risk of insufficient drying following sterilisation. No complaints, wet product incidents, or patient harm have been reported to date. |
| Recall action type: | Correction |
| Recall action: | Instructions for use to be updated |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 29/6/2026 |
