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 29221–29240 of 38,428 recalls
Recalled Item: Exprt Precision System: Revision Knee
The Issue: The labeling is missing the size/diameter information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is
The Issue: Images may be missing when a system parameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AltiVate Humeral Socket Shell Trial
The Issue: Difficulty assembling the shell trial to the broach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Medical Device Identification Card for SureScan pacemaker...
The Issue: Some Medical Device Identification Cards provided to SureScan
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco Radiation Treatment Planning System. Used to make treatment plans
The Issue: Dose and MU are incorrect when CT images
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size
The Issue: SPAG-2 6000 Lot J3522070 was released to commerce
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONSULT(TM) diagnostics hCG CONTROLS Kit
The Issue: CONSULT diagnostics hCG Controls have discrepant storage temperatures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Samsung GM60A-40S Intended for use in generating radiographic images of
The Issue: When the system is driving over a non-conductive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MILEX PESSARY KIT
The Issue: The products have been identified to have incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 Computed Tomography X-ray systems. Intended to produce...
The Issue: The firm discovered Ring/Dot artifact due to X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Computed Tomography X-ray systems. Intended to produce...
The Issue: The firm discovered Ring/Dot artifact due to X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce
The Issue: The firm discovered Ring/Dot artifact due to X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems.
The Issue: The firm discovered Ring/Dot artifact due to X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Flex Computed Tomography X-ray systems. Intended to produce...
The Issue: The firm discovered Ring/Dot artifact due to X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce
The Issue: The firm discovered Ring/Dot artifact due to X-ray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turon Shoulder Impaction Fixture The Turon and RSP
The Issue: During the Turon assembly, the impaction forces caused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reverse Shoulder Prosthesis Stem Impaction Fixture The Turon
The Issue: During the assembly, the impaction forces caused the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORT-A-CATH Plastic Hub Needles
The Issue: The label on the lid stock of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates
The Issue: Affected lots of Periarticular Aiming Arms and Insertion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P/N: 9734856
The Issue: Specific use conditions can increase the possibility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.