FDA (Devices) recall action 68145
The FDA (Devices) publishes a recall like this one as 25 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 25 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 sterile O-Arm devices because returned units may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 disposable sterile devices because returned units may not have been properly examined for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 AxIEM CR tumor resection devices because returned units may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 biopsy needle kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 single-use, disposable navigation devices because returned units were not adequately examined for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 thoracic tactile probe kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 Traj Guide Kits because returned devices may not have been properly inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 non-invasive shunt kits because returned devices were not adequately inspected for damage that could compromise sterility.
Medtronic Navigation is recalling single-use instrument trackers because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 single-use disposable devices because returned items were not adequately inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 single-use Ref Frame Driver Kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 single-use spine pedicle accessory kits because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling sterile mouse bags because returned devices may not have been properly examined for damage that could compromise sterility.
Medtronic Navigation is recalling single-use, disposable devices because returned items were not adequately inspected for damage that could compromise sterility.
Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.
Medtronic Navigation is recalling 26,674 ENT PRGM 9734636 ADD FUSION NAV AxiEM devices because returned units may not have been properly examined for damage to ensure sterility.