Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 38161–38180 of 38,428 recalls
Recalled Item: Cardiogenesis Corporation - Cardiogenesis Transmyocardial Laser. The device...
The Issue: Following acquisition of Cardiogenesis, we began receiving complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Laboratory SMART & Sunquest Laboratory SMART Select
The Issue: In Online Entry (OEx) there are two scenarios
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IO FiX X-Post Reamer
The Issue: Product Event Reports revealed a broken reamer experienced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IO Fix IntraOsseous Fixation System
The Issue: Product Event Reports revealed that lag screw passes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed
The Issue: GE Healthcare conducted a recall involving 2 events
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femoral
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 MIS
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 MIS
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 MIS
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Femoral
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 MIS
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Femoral
The Issue: Complaints have been received reporting sub-optimal fit between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnspacSingle use Sterile bone cutting burs.h Twist Drill
The Issue: Cutter was longer than was stated on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anspach Twist Drill for 1.5mm x 4mm screw.
The Issue: Cutter was longer than was stated on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: When performing a secondary capture generated from GSI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.