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 37341–37360 of 38,428 recalls
Recalled Item: Interface module for CDl System 100/101 Product Usage: The Interface
The Issue: Terumo Cardiovascular Systems has received reports of malfunctions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Serial interface module RS-485 Product Usage: The System 1 provides
The Issue: Terumo Cardiovascular Systems has received reports of malfunctions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System 1 base 220/240V The Terumo Advanced Perfusion System 1
The Issue: Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: System 1 base 100/120V The Terumo Advanced Perfusion System 1
The Issue: Terumo Cardiovascular Systems sent a Safety Advisory (AA-2010-007-C)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Myocardial Heart Wires Intended for temporary atrial and ventricular pacing
The Issue: Oscor, Inc. in Palm Harbor, FL is recalling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T
The Issue: There is a possibility that the screw channel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions
The Issue: Decrease in onboard dilution recovery when using Multi-Diluent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Essenta DR
The Issue: Essenta DR C-Arm may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The
The Issue: A component within the handle of the Expedium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Folate WHO Calibrators
The Issue: Beckman Coulter is recalling the Access Folate Calibrators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Folate Calibrators
The Issue: Beckman Coulter is recalling the Access Folate Calibrators
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended
The Issue: Customers who received a Capintec Captus 3000 Thyroid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altrx" Altralinked" Polyethylene liners Description: An acetabular liner is one
The Issue: In the recalled lot, the products were not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VersaTREK Windows Software
The Issue: Review of instrument software databases and investigation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cisco brand HealthPresence
The Issue: Software anomaly may result in incorrect values and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE Monitor B850 Product Usage: The CARESCAPE TM Monitor B850
The Issue: GE Healthcare become aware of 4 potential issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visual-ICE¿ Cryoablation System
The Issue: Galil Medical is recalling a number of Visual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TAUT
The Issue: Product is missing the label on the internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laserworld RGB & Piko Nano RGB Models All models are
The Issue: A potential lack of certification, and/or missing laser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1
The Issue: Abbott Point of Care (APOC) has determined that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.