Medtronic Recalls Single-Use Disposable Devices Due to Sterility Control Issues
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately 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, which typically indicates a situation where use of the product could cause temporary or medically reversible health consequences. The source text describes a lack of control over sterility assurance for returned devices, which is a significant quality issue but does not explicitly report injuries or hospitalizations, fitting the Moderate category for a precautionary recall regarding potential sterility compromise.
Plain-English summary
Medtronic Navigation, Inc. is recalling certain single-use, disposable devices. The recall is being conducted because the company did not have sufficient controls to ensure that returned, unused devices were appropriately examined for product and/or package damage. This lack of inspection could potentially compromise the sterility of the devices.
The affected product is identified as SPHERES 8801075 5/TRAY 12PK. The recall covers 26,674 total units distributed nationwide. Specific lot numbers involved in this recall include 1207251, 1301091, 1301081, 1211141, 1301151, 1302051, 1303141, 1303121, 1303191, 1304031, 1304081, 1303071, 1305221, 1305281, 1306181, 1306231, 1307041, 1307051, 1307111, 1307131, and 1307121.
Healthcare providers and facilities should stop using these devices and contact Medtronic Navigation for instructions on how to return or dispose of the affected units. Patients who have already received treatment with these devices should contact their healthcare provider if they have concerns about potential sterility issues.
The recalled product
- Product
- SPHERES 8801075 5/TRAY 12PK
- 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.
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