Medtronic Recalls Sterile O-Arm Devices Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 sterile O-Arm 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: This is a Class II recall involving a potential sterility issue due to inadequate inspection of returned devices. No illnesses or injuries are reported, and the hazard is theoretical, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the MOUSE 9732721 STERILE O-ARM 10PK. These are single-use, disposable medical devices distributed nationwide. The recall involves specific lot numbers: 5051140611, 5336060213, 5162060112, and 4734921009.
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 inspection could potentially compromise the sterility of the devices.
Healthcare providers and facilities that have received these devices should stop using them and contact Medtronic Navigation for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- MOUSE 9732721 STERILE O-ARM 10PK
- 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.: 5051140611 5336060213 5162060112 4734921009
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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