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 4061–4080 of 38,428 recalls
Recalled Item: Aligned Medical Tonsil Tray that contains the Cardinal
The Issue: Due to convenience kits containing a kit component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Septo Pack that contains the Cardinal
The Issue: Due to convenience kits containing a kit component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical T and A Pack that contains
The Issue: Due to convenience kits containing a kit component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Tonsil Pack that contains the Cardinal
The Issue: Due to convenience kits containing a kit component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aligned Medical Tonsil ENT Pack that contains the
The Issue: Due to convenience kits containing a kit component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems
The Issue: If ultrasound systems with software, are changed from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Maple 1.0 Diagnostic Ultrasound System
The Issue: If ultrasound systems with software, are changed from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Juniper 1.0
The Issue: If ultrasound systems with software, are changed from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Creatine Kinase (CK) used on cobas c 311/501/502 and COBAS
The Issue: Creatine Kinase (CK) Assay Abnormal calibrations on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris EtCO2 Module Model 8300
The Issue: Due to affected devices that may have bent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to
The Issue: Incomplete insertion of the patient connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Pump Module Model 8100
The Issue: Due to affected devices that may have bent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood
The Issue: Incomplete insertion of the patient connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood
The Issue: Incomplete insertion of the patient connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer
The Issue: Incomplete insertion of the patient connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLINE LONG-Tubing to be used to transfer blood between a
The Issue: Incomplete insertion of the patient connector of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PCA Module Model 8120
The Issue: Due to affected devices that may have bent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC Unit Model 8015 - a modular infusion pump and monitoring system
The Issue: Due to affected devices that may have bent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the
The Issue: Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Microalbumin_2 (¿ALB_2) -For in vitro diagnostic use in
The Issue: Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.