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 17341–17360 of 38,428 recalls
Recalled Item: SOMATOM Drive
The Issue: for four safety-related software issues impacting systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Force
The Issue: for four safety-related software issues impacting systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Edge Plus
The Issue: for four safety-related software issues impacting systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge
The Issue: for four safety-related software issues impacting systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash
The Issue: for four safety-related software issues impacting systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Confidence
The Issue: for four safety-related software issues impacting systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco RTP System
The Issue: When creating 3D plans using either MU or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GammaPod Stereotactic Radiotherapy System Model A
The Issue: One bolt on the V motor was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Snapshot Tracker Kit
The Issue: The firm has become aware that the Snapshot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoolBlue Hyper-Hypothermia System- body hypothermia system Model: Innercool...
The Issue: Warnings statements have been added- exceeding 40 degree
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blanketrol III Hyper-Hypothermia System- body hypothermia system temperature...
The Issue: Warnings statements have been added- exceeding 40 degree
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blanketrol II Hyper-Hypothermia System
The Issue: Warnings statements have been added- exceeding 40 degree
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric
The Issue: The firm conducted internal investigations that confirmed customer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAsymphony SP SOW 5.0.3
The Issue: QIAsymphony software version 5.0.3 - Software issue incorreclty
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151812
The Issue: Cleaning processes potentially being ineffective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151811
The Issue: Cleaning processes potentially being ineffective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151810
The Issue: Cleaning processes potentially being ineffective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151815
The Issue: Cleaning processes potentially being ineffective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151813
The Issue: Cleaning processes potentially being ineffective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Hybrid Poly Tibia Item # 151814
The Issue: Cleaning processes potentially being ineffective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.