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 37081–37100 of 38,428 recalls
Recalled Item: The RIO (TGS 2.)
The Issue: MAKO Surgical Group recalled their RIO System software,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Digital Diagnost with patient carriage Model: 712050 with serial
The Issue: Hook does not securely hold the footplate in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Magnetom Skyra
The Issue: When positioning the Flex Large 4 Coil (part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-Ray System Brilliance Workspace Portal
The Issue: Philips was notified that when performing post processing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens ADVIA Centaur BR Assay: Catalog Number: US:
The Issue: BR Assay for CA 27.29 Calibration Interval Change
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL M4735A Defibrillator/Monitors
The Issue: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STREAMLINE CT CERVICO-THORACIC SYSTEM
The Issue: Some set screw thread profiles were found not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility
The Issue: The potential exists for the wheel to rotate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage:
The Issue: Terumo Cardiovascular Systems (CVS) received two reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Titanium Minimally Invasive Reduction Screw System Polyaxial Screw Body
The Issue: This action is being initiated following a detailed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Titanium Minimally Invasive Reduction Screw System Locking Cap
The Issue: This action is being initiated following a detailed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instrumentation Industries BE183-SU and BE 183 SU-12 Manual Jet Ventilators
The Issue: Firm initiated an update to Directions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: materials "RETINAL OCT Analysis and Interpretation Method" shipped with
The Issue: Devices labeled for an intended use not included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Clearlink System Buretrol Solution Set
The Issue: Baxter has determined that the ball-valve feature of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Interlink System Buretrol Solution Set
The Issue: Baxter has determined that the ball-valve feature of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Clearlink System Buretrol Solution Set
The Issue: Baxter has determined that the ball-valve feature of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Interlink System Buretrol Solution Set with 150 mL Burette
The Issue: Baxter has determined that the ball-valve feature of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc
The Issue: The 8 Fr. Bardex All-Silicone Foley Catheter with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cemented Tibial Drill Product Usage: The cemented tibial drill is
The Issue: Zimmer is initiating a recall of the Cemented
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK
The Issue: Fracture of SPIRALOK Anchors post op, requiring patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.