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 16841–16860 of 38,428 recalls
Recalled Item: BIOFLO 8F SINGLE PLASTIC NON-FILLED
The Issue: Snap lock connectors provided within implantable port kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemo-Drop Blood Dispenser
The Issue: The metal cannula of the device either broke
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Manual Diff Dropper
The Issue: The metal cannula of the device either broke
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eversense CGM SENSOR (FG-4200-00-301)-Continuous Glucose Monitor
The Issue: Eversense Sensors have prematurely stopped functioning due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the
The Issue: ability to leak once used for compounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pneumothorax Tray
The Issue: Lidstock perforation line may be over the sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceCure Cryoablation System ProSense -Intended for cryogenic destruction of...
The Issue: Updated User Manual DSR3200000 Rev. E to include
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KT RECOVERY+ ICE/HEAT MASSAGE BALL Rolling ball with hot and
The Issue: If over-heated may leak which, if not noticed,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BodyGuard Microset
The Issue: When using a specific tubing set with infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product
The Issue: Conical Cannulated Screws may not accept 1.6mm K-Wire,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product :
The Issue: Conical Cannulated Screws may not accept 1.6mm K-Wire,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
The Issue: There is a potential performance issue as detected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
The Issue: There is a potential performance issue as detected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axis-Shield Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT
The Issue: There is a potential performance issue as detected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accessory kit
The Issue: reliability issue with the Alinity ci series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity ci Level Sensor
The Issue: reliability issue with the Alinity ci series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accessory kit
The Issue: reliability issue with the Alinity ci series
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI:
The Issue: A portion of the lot was incorrectly packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAROS Oxygen System Model 3000
The Issue: There is an electronics control issue that causes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioLab/ComboLab Recording Systems
The Issue: for failure of the patient leakage current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.