Nitinol Devices and Components recalls

Nitinol Devices and Components has 12 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 2 Jul 2014. The most frequent reason is sterility.

Total recalls12since 2014

Last 12 months0reported

Class I12100% of total

Ongoing0latest 2 Jul 2014

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 12 100%Class II 0 0%Class III 0 0%

Why nitinol devices and components is recalled

Sterility1192%
Other Reasons18%

Product types

Heart & Vascular Devices12100%

By year

201412100%

All nitinol devices and components recalls, newest first

12 total

Reported	Class	Recall	Company	Reason	Where
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire;Nitinol Guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire;Nitinol Guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide
2 Jul 2014Device	CLASS I	HydroFinity Hydrophilic guidewire recalled	Nitinol Devices and Components	Sterility	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.