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 21381–21400 of 38,428 recalls
Recalled Item: Visaris Vision/Auto
The Issue: A failure of the tube arm suspension is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoratec HeartMate 3 LVAS Implant Kit
The Issue: Reports of outflow graft twist occlusions. Patients whose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visaris Vision/Auto
The Issue: A failure of the tube arm suspension is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactosorb RapidFlap
The Issue: The recalling firm has confirmed that the Outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein CU 1000 Halogen Curing Light
The Issue: Tip of the curing light was too hot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOHELP Gas Bottle Holder HKH 8880
The Issue: There is a possibility for the clamps of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS IMRI 1.5T AND 3T S System Product Usage: The
The Issue: The DC power to the IFOSS collision detector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CELLSEARCH¿ CIRCULATING Tumor Cell Kits (IVD) (Product Code 7900001) CELLSEARCH¿
The Issue: Unusually high number of total images/unassigned events may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas e 801 immunoassay analyzer
The Issue: The syringe plunger on the device may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version
The Issue: Service technician improperly documented final release testing on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version
The Issue: Service technician improperly documented final release testing on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version
The Issue: Service technician improperly documented final release testing on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version
The Issue: Service technician improperly documented final release testing on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version
The Issue: Service technician improperly documented final release testing on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Modular Arthrodesis 0 Degree Locking Collar
The Issue: There is a potential dry blast irregularity on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AesDex
The Issue: Following pressurization of the devices, damage to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PR4100 Microplate Reader US
The Issue: The connector of the power supply was capable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AesDex
The Issue: Following pressurization of the devices, damage to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T2100 Micro flex Drive Treadmill
The Issue: A performance issue with customer owned spare parts,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bivona¿ Tracheostomy Tube Tracheostomy Tubes
The Issue: Carton labeling is printed with "Sterile" indicated labeling,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.