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 29961–29980 of 38,428 recalls
Recalled Item: Hamilton Medical Infant Flow Sensor
The Issue: An issue has been discovered with the Hamilton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton Medical Infant Flow Sensor
The Issue: An issue has been discovered with the Hamilton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton Medical Infant Flow Sensor
The Issue: An issue has been discovered with the Hamilton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannula and Seal
The Issue: Stryker Sustainability Solutions is recalling Trocars because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optical Access System
The Issue: Stryker Sustainability Solutions is recalling Trocars because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fios First Entry
The Issue: Stryker Sustainability Solutions is recalling Trocars because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Laksell GammaPlan
The Issue: Memory can become corrupted when creating a fused
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Schiller PB 1000
The Issue: Non-invasive blood pressure pumps (NIBP) voltage is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiation Therapy Treatment Planning System software RayStation is a software
The Issue: An error caused by a floating point precision
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Triathlon X3 Tibial Bearing Insert - CR REF
The Issue: Stryker has received a report which identified that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triathlon PS X3 Tibial Insert
The Issue: Stryker Orthopaedics received a report that 5537-G-319 No
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InjectionPlasty 1.0 Bone Void Filler
The Issue: Reports of venous uptake, DVT, pulmonary embolism in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PowerLED / X-TEN / VOLISTA Surgical Light Systems are
The Issue: Maquet Suspension Arms used with PowerLED/X-TEN/Volista Surgical Light
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Songer Spinal Cable System
The Issue: The box end label is incorrectly labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima IGS 320. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A
The Issue: When performing a 2D Stress Echo study, some
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite F500
The Issue: A firmware bug causes incorrect values to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Discovery IGS 730. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Optima CL 323i. Angiographic X-ray systems used in
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Innova 2121IQ. Angiographic X-ray systems used in generating
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.