Medtronic Recalls AxIEM CR Tumor Resection Devices Due to Sterility Concerns
Medtronic Navigation is recalling 26,674 AxIEM CR tumor resection devices because returned units 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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a potential sterility breach due to a process control failure, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the PACK 9731975 TUMOR RESECTION AXIEM CR. These are single-use, disposable medical devices distributed nationwide. The specific lot number for the affected devices is 0006922410.
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 means there is a risk that the sterility of the devices may have been compromised.
Healthcare facilities and consumers who have these devices should stop using them and contact Medtronic Navigation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- PACK 9731975 TUMOR RESECTION AXIEM CR
- 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.: 0006922410
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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