Medtronic Recalls Tumor Resection Kits Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure 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 hospitalizations, injuries, or illnesses. It is a precautionary recall regarding process controls for sterility assurance, fitting the 'voluntary precautionary recalls' criterion for a Moderate score.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the Tumor Resection Kit 9733608 Skull Mount. These are single-use, disposable medical devices distributed nationwide. The affected lots are 120725D and 130404B.
The recall was initiated because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. This lack of control raises concerns about the ability to ensure the sterility of the devices.
Healthcare facilities and consumers should stop using these specific devices and contact Medtronic Navigation for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- TUMOR RESECTION KIT 9733608 SKULL MOUNT
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 26,674
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot No.: 120725D 130404B
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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