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 25501–25520 of 38,428 recalls
Recalled Item: Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N
The Issue: Four lots of Tiger Screw Sterilization Tray Base
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego
The Issue: Siemens initiated a corrective action to address two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q/Q.zen
The Issue: Siemens initiated a corrective action to address two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIAMONDBACK 360 Peripheral 1.50 Classic
The Issue: CSI discovered that a 1.50mm Solid Crown OAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medacta International SA
The Issue: Damaged packaging, lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Component Fixed Hinge Small Long
The Issue: The recalling firm has received 5 customer inquiries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Integral Shaft & Stem 15x27 HA Coated
The Issue: The recalling firm has received 5 customer inquiries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DF Coated Integral Shaft & Stem 15x30x38
The Issue: The recalling firm has received 5 customer inquiries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Shaft L=120mm
The Issue: The recalling firm has received 5 customer inquiries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Component Metal Cased Small Long
The Issue: The recalling firm has received 5 customer inquiries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxford Fixed Lateral Bearing Size F Right
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Ablation Catheter Cable Catalog Number: CR3425CT
The Issue: A breach in the sterile packaging may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT
The Issue: A breach in the sterile packaging may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife Robotic Radiosurgery Systems
The Issue: Accuray has become aware of a potential safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPT Croutons is a synthetic bone substitute designed for the
The Issue: OPT Croutons, part number 65-0210-S, is recalled due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnLite Neonatal TREC Kit
The Issue: Unique Device Identifier (UDI) is missing from outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A1CNow SELF CHECK (European)
The Issue: A numerical value less than 4% or greater
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVS Health At Home A1C Test Kit
The Issue: A numerical value less than 4% or greater
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A1CNow+ Systems (professional use product)
The Issue: A numerical value less than 4% or greater
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReliOn FastA1C Test
The Issue: A numerical value less than 4% or greater
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.