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 27841–27860 of 38,428 recalls
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/zeego and Artis Q/Q.zen system
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique
The Issue: When testing was conducted using certain lots, VITROS¿
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Livongo Health In Touch¿ Blood Glucose Monitoring System (BGMS)
The Issue: The instructional insert for the In Touch Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oblique Posterior Atraumatic Lumbar (OPAL) System
The Issue: The label on the outer packaging does not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis zee/zeego
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis zee/zeego
The Issue: Due to a leak in the cooling system,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including
The Issue: McKesson has identified a design deficiency where under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROTROL P Control for ROTEM delta Thromboelastometry System
The Issue: Customer complaints about failed target ranges for alpha
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catheter
The Issue: Notification of component molding abnormality by supplier used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cather
The Issue: Notification of component molding abnormality by supplier used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catheter
The Issue: Notification of component molding abnormality by supplier used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Catheter
The Issue: Notification of component molding abnormality by supplier used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Quick Adjust under the following labels: 1) Aluminum crutch
The Issue: Tip crutch failure involving the bottom of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.