FDA Device recall Z-1596-2014
SPHERES 8801075 5/TRAY 12PK
- FDA Device
- Class II
- terminated
- Published 2014-11-26
On 2014-11-26 the FDA classified a Class II recall of SPHERES 8801075 5/TRAY 12PK by Medtronic Navigation, citing medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1596-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-24 |
| Published | 2014-11-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
Product
SPHERES 8801075 5/TRAY 12PK
Reason
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Identifiers
| code_info | Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1…Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1596-2014%22
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