Medtronic Navigation, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1596-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

SPHERES 8801075 5/TRAY 12PK

Product Classification:

Class II

Date Initiated: April 24, 2014

Date Posted: November 26, 2014

Recall Number: Z-1596-2014

Event ID: 68145

Reason for Recall:

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.

Status: Terminated

Product Quantity: 26,674 total

Code Information:

Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121

Distribution Pattern:

Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated