Medtronic Recalls Traj Guide Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical risk to sterility due to process control issues, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the Traj Guide Kit (Catalog No. 9733065, Biopsy, Ext). These are single-use, disposable medical devices distributed nationwide.
The recall was initiated because the company did not have sufficient controls to ensure that returned, unused devices were appropriately examined for product or package damage. This lack of inspection could potentially compromise the sterility of the devices.
Consumers and healthcare facilities should stop using these devices and contact Medtronic Navigation for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- TRAJ GUIDE KIT, 9733065, BIOPSY, EXT
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 26,674
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 25 recalled by Medtronic Navigation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 25 products in this recall →Related recalls
Same manufacturer · Medtronic Navigation, Inc.
See all →- HighMedtronic Percutaneous Reference Pins May Not Fit Properly
FDA (Devices) · 2025-02-05
- HighStealthStation S8 Spine Surgery Navigation System Recalled for Software Defects
FDA (Devices) · 2024-10-16
- SevereStealth S8 neurosurgical navigation software display error affecting surgical guidance
FDA (Devices) · 2024-05-15
- HighMedtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects
FDA (Devices) · 2024-01-17
- HighMedtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues
FDA (Devices) · 2024-01-17
Same hazard · sterility compromise
See all →- ModerateAVID Medical Recalls Halyard IV Start Kits Due to Packaging Seal Issues
FDA (Devices) · 2026-09-30
- HighMedline Recalls Cataract Convenience Kits Due to Open Sterile Seals
FDA (Devices) · 2026-09-23
- HighMedline Myringotomy Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMedline Anesthesia Pain Kits Recalled for Potential Sterility Compromise
FDA (Devices) · 2026-09-23
- HighMaquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues
FDA (Devices) · 2026-09-23
Similar recalls
- HighBiomet 3i Recalls Tapered Navigator Surgical Kits Due to Sterility Failure
FDA (Devices) · 2014-03-19
- SevereMedline Tracheostomy Convenience Kits Recalled Over Sterilization Calibration Concerns
FDA (Devices) · 2026-02-25
- CriticalMedline Medical Kits Recalled Due to Potential Lack of Sterility
FDA (Devices) · 2024-03-06
- SevereMedtronic Guide Catheter Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2021-03-17
- SevereMedline Surgical Kits Recalled for Potential Sterility Failure
FDA (Devices) · 2024-03-06
- SevereMedline Tracheostomy Care Kits and Trays Recalled Due to Sterility Concerns
FDA (Devices) · 2024-03-06