Medtronic Recalls Disposable Sterile Surgical Devices Due to Sterility Concerns
Medtronic Navigation is recalling 26,674 disposable sterile devices because returned units may not have been properly examined 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 product (sterile medical device) where injury has not yet been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Medtronic Navigation, Inc. is recalling certain single-use, disposable devices identified as DISP 9730951 STRL SPHERE, 5PK INSERT. The recall involves 26,674 units distributed nationwide under Lot No. B155300281.
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 devices and contact Medtronic Navigation for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- DISP 9730951 STRL SPHERE, 5PK 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.: B155300281
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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