Medtronic Recalls Single-Use Disposable Devices Due to Sterility Control Issues
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately examined for damage to ensure sterility.
What this means for you
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 (sterility failure) 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. The recall involves 26,674 units of the product identified as SPHERES 8801071 1/TRAY 12PK. The affected lots are 1203122, 1205291, 1206251, 1306081, and 1309101. These devices were distributed nationwide.
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 meant the company could not ensure the sterility of the devices.
Consumers and healthcare providers should stop using these devices and contact Medtronic Navigation for instructions on how to return them or obtain a replacement.
The recalled product
- Product
- SPHERES 8801071 1/TRAY 12PK
- 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.: 1203122 1205291 1206251 1306081 1309101
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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