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 27321–27340 of 38,428 recalls
Recalled Item: MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage:
The Issue: A potential problem associated to the gradient coil
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite
The Issue: BBMI recently identified a potential for a tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CytoScan¿ Dx Assay. The CytoScan Dx Assay consists of five reagent modules
The Issue: During a recent Ohio site inspection by the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve Product Usage:
The Issue: BBMI recently identified a potential for a tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LenSx Laser System. Indicated for use in patients undergoing cataract
The Issue: Alcon is conducting a voluntary recall of all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for
The Issue: MRx monitor/defibrillators could fail to charge because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentaray NAV High-Density Mapping Catheter
The Issue: Biosense Webster is recalling the Pentaray Catheters to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentaray NAV High-Density Mapping ECO Catheter
The Issue: Biosense Webster is recalling the Pentaray Catheters to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo Dynamics
The Issue: Siemens has identified changes in default carry forward
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. The firm name on the label is Merge Healthcare
The Issue: Fetal patient report was automatically pulling prior measurement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactate
The Issue: Beckman Coulter has identified that Dipyrone (Metamizole) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cholesterol
The Issue: Beckman Coulter has identified that Dipyrone (Metamizole) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lipase
The Issue: Beckman Coulter has identified that Dipyrone (Metamizole) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triglyceride
The Issue: Beckman Coulter has identified that Dipyrone (Metamizole) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uric Acid
The Issue: Beckman Coulter has identified that Dipyrone (Metamizole) may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Battery Pack Used with the Capnostream"20 and Capnostream"20p Patient Monitor
The Issue: Medtronic Respiratory & Monitoring Solutions Announces a Voluntary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAGNETOM Aera/Skyra Systems
The Issue: The docking station top cover of the removable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novation Press-Fit Tapered
The Issue: Devices were inadvertently sent to packaging and finished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novation Ceramic AHS Cluster-Hole Shell
The Issue: Devices were inadvertently sent to packaging and finished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novation Press-Fit Tapered
The Issue: Devices were inadvertently sent to packaging and finished
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.