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 21781–21800 of 38,428 recalls
Recalled Item: Strauss Penis Clamp 130MM/General Instruments
The Issue: The plastic sleeves of the Penis Clamp and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Doyen-Collin Mouth Gag 120MM/ General Instruments
The Issue: The plastic sleeves of the Penis Clamp and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The DABRA Laser (model RA-308) is designed to provide ultraviolet
The Issue: Lasers/Catheters did not calibrate during set-up prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Sensation 10 Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Transonic ADT1018 Flow QC Clear Advantage Tubing
The Issue: The sterility of the device cannot be assured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Perspective Intended to produce cross-sections images of the body
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Spirit Intended to produce cross-sections images of the body
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Sensation Open Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Scope Intended to produce cross-sections images of the body
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Scope Power Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Sensation 64 Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Emotion (2003) Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Sensation 40 Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Sensation Cardiac Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Emotion 16 Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Perspective 16 Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of
The Issue: To inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Emotion 6 Intended to produce cross-sections images of the
The Issue: To inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Sensation 16 Intended to produce cross-sections images of the
The Issue: to inform customers of possible incorrect tube current
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT
The Issue: Following a period of inactivity, the mass storage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.