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 601–620 of 38,428 recalls
Recalled Item: GE HealthCare ViewPoint 6
The Issue: GE HealthCare has become aware that the Patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Forza" Ti Spacer System Product Name: Forza" Ti
The Issue: Labeling contains claims that are not consistently present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX"
The Issue: Labeling contains claims that are not consistently present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX"
The Issue: Labeling contains claims that are not consistently present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI
The Issue: Labeling contains claims that are not consistently present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pillar" SA PTC Spacer System Product Name: Pillar"
The Issue: Labeling contains claims that are not consistently present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Organic Acids Profile Test Large
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FORZA" PTC Spacer System Product Name: FORZA" PTC
The Issue: Labeling contains claims that are not consistently present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Food Intolerance Test Small
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitamin D-Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Candida Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allergy Test IgE
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allergy test Small
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GI Microbiome Profile XL
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Illegally Marketed
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HPV Antigen Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sperm Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mycoplasma test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: Downstream Occlusion alarms may occur during procedures using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcohol (ALC) Test Saliva
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.