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 15281–15300 of 38,428 recalls
Recalled Item: K2M
The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2M
The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2M
The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2M
The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2M
The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K2M
The Issue: The Aleutian Anatomically Narrow Lordotic Spreader was manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic
The Issue: Restorations crack during the sintering process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A2 C17/5 -
The Issue: Restorations crack during the sintering process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use
The Issue: Restorations crack during the sintering process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A1 C17/5 -ceramic for dental use
The Issue: Restorations crack during the sintering process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Implantable Insulin Pump System
The Issue: Internal testing results showed endotoxin-related test result did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Processor Board PCA Replacement Kits 453563478461
The Issue: Damaged ESD bags used for storing components in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Zenition 70
The Issue: When strain relief is lost at the stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Zenition 50
The Issue: When strain relief is lost at the stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CooperSurgical Dilator/Sound Set
The Issue: The seal of the sterile pouch may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700....
The Issue: A software issue that may affect the analyzer's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris PCEA Administration Set
The Issue: The products have the potential to leak between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris PCEA Administration Set
The Issue: The products have the potential to leak between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris PCEA Administration Set
The Issue: The products have the potential to leak between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WRIGHT INBONE Tibial Tray
The Issue: One lot of INBONE Tibial Trays is missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.