Medtronic Recalls Disposable Surgical Devices Due to Sterility Control Issues
Medtronic Navigation is recalling 26,674 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of harm (compromised sterility) for a medical device where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a High severity score.
Plain-English summary
Medtronic Navigation, Inc. is recalling 26,674 units of the DISP 9730950 STRL SPHERE, 1 PK INSERT. These are single-use, disposable medical devices distributed nationwide. The specific lot number affected is B135276281.
The recall was initiated because the manufacturer did not have sufficient controls to ensure that returned, unused devices were properly 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.
Consumers and healthcare facilities should stop using these devices and contact Medtronic Navigation for instructions on how to return or dispose of them. The recall is classified as Class II by the FDA.
The recalled product
- Product
- DISP 9730950 STRL SPHERE, 1 PK INSERT
- 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.: B135276281
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
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