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 33781–33800 of 38,428 recalls
Recalled Item: Sarns Dual-stage Venous Return Cannulae
The Issue: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Malleable Dual-stage Venous Return Cannulae
The Issue: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Dual-stage Venous Return Cannulae
The Issue: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sarns Malleable Dual-stage Venous Return Cannulae
The Issue: During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific
The Issue: The sterile pouch of the devices from this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omni Micro-electrode/ electrode for cobas b221 analyzer
The Issue: Reference electrode used beyond the guaranteed in-use 52
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube
The Issue: The product may fail to achieve seal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound
The Issue: A problem has been detected with Philips Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound
The Issue: A problem has been detected with Philips Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239
The Issue: GE Healthcare has recently become aware of potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Activa RC (37612)
The Issue: Medtronic neurostimulators (used with pain and deep brain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic neurostimulators. Restore (37711)
The Issue: Medtronic neurostimulators (used with pain and deep brain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Medtronic neurostimulators (used with pain and deep brain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-10" Hemoglobin Testing System
The Issue: On a rare occasion the D-10 software might
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerPort Slim Implantable Port
The Issue: Labeling discrepancy.The label states that the implantable port
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ovation Prime Abdominal Stent Graft System
The Issue: Communication to European physician users of the Ovation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hand Control 12FR Suction Coagulator with 10 ft cord and holster
The Issue: Megadyne Medical Products, Inc. is voluntarily recalling Hand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safety glasses made with "Rage" frames manufactured between February 20
The Issue: Fifteen pairs of prescription, safety glasses did not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi...
The Issue: Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed¿ II Implantable Drug Infusion Pump
The Issue: This recall provides important new information regarding overinfusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.