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 8681–8700 of 38,428 recalls
Recalled Item: EMPOWR Porous Knee Patella Over Drill
The Issue: Patella drills are marked with incorrect diameter size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: There is an issue related to the Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: There is an issue related to the Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Intra-Aortic Balloon Pump (IABP) Safety Disk
The Issue: There is an issue related to the Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Intra-Aortic Balloon Pump (IABP) Pneumatic Interface Module (PIM)
The Issue: There is an issue related to the Safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM
The Issue: The external diameter of the biopsy instrument is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System. Used to make treatment plans for patients
The Issue: Re-optimization, after adding contours without forced density outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RelieVR
The Issue: There is the potential for the program software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FujiFilm FDR AQRO (Model DR-XD1000)- A digital mobile X-ray system
The Issue: Arm which holds the tube head in place
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoCr Femoral Head
The Issue: Update the compatibility matrix as referred to in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tobii Dynavox TD I-110 Speech Device-tablet style speech generating device
The Issue: Problem maintaining the stable placement of the battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Iradimed Corporation MRidium MRI 1000 Series Infusion Sets
The Issue: Certain Iradimed 1057 Syringe Adapter Sets, used with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Caspar Cervical Retractor (CCR) Basket ME754 - Lid Only and
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Rotatable Clip Fixing Device Model HX 201LR 135 - Rotatable
The Issue: There have been complaints that the clip did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tempus Pro Patient Monitor is a portable vital signs monitor
The Issue: During internal testing, Regulatory Compliance issues were identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated Peritoneal Dialysis System. Used for automatic control of dialysis
The Issue: The electrical safety testing was not properly performed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200
The Issue: Bio-Rad received four customer complaints from 11/30/2022 to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200
The Issue: Bio-Rad received four customer complaints from 11/30/2022 to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath
The Issue: Incorrect labeling; specifically, the product name, lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biosense Webster Carto Vizigo Bi-Directional Guiding Sheath
The Issue: Incorrect labeling; specifically, the product name, lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.