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 5201–5220 of 38,428 recalls
Recalled Item: The Synchro SELECT Guidewires are a steerable guidewire family with
The Issue: Stryker Neurovascular has observed an increased frequency of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Synchro Neuro Guidewires are a steerable guidewire family with
The Issue: Stryker Neurovascular has observed an increased frequency of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OES 4000 Hysteroscope
The Issue: The required leakage test was not performed following
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG:
The Issue: Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optum Nimbus II Plus
The Issue: Nimbus II Plus, Infusion Pump Systems, manufactured by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syringes labeled as: a) SYR 10ML L/L CONTROL
The Issue: These syringes were identified to be affected by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Pump Rotor
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra¿ Cranial access kit (without Prep solutions) Bit and Guard-
The Issue: holes and tears in the sterile packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T BlueStar Hemodialysis Machine
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T BlueStar Hemodialysis Machine
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T BlueStar Hemodialysis Machine
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T BlueStar Hemodialysis Machine
The Issue: An increased number of complaints were reported on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optical Inspection System
The Issue: Non-medical laser products which were determined to not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Yamaha Surface Mounter YR series
The Issue: Non-medical laser products which were determined to not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syntel Silicone Thrombectomy Catheter
The Issue: The guide tip can become damaged and result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in.
The Issue: contamination of the product with latex adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intelli-C: Right side suspended Tabletop
The Issue: X-ray system C-arm may experience uncontrolled motion if
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVERA MRI S VR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT DR MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT HF QUAD CRT-D MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.