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 26661–26680 of 38,428 recalls
Recalled Item: MOSAIQ Oncology Information System
The Issue: It is possible that a change to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salivary Estradiol ELISA
The Issue: Lower recovery of salivary estradiol levels due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroVue BAP EIA
The Issue: There is a possibility of low volume and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge RadSuite
The Issue: It was reported by a customer that RadSuite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microtek Franz Angiography Drape with Radiation Shield
The Issue: Ecolab is recalling 2 models of Angiography Drapes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAPLER
The Issue: Field failures were reported related to the da
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAPLER 30
The Issue: Field failures were reported related to the da
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CURVED-TIP STAPLER 30
The Issue: Field failures were reported related to the da
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann Bone Level Implant
The Issue: Misalignment with the Loxim transfer piece markings, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straumann Bone Level Implant
The Issue: Misalignment with the Loxim transfer piece markings, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAPLER 45
The Issue: An increase in the number of da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Estradiol Reagent Pack
The Issue: Ortho Clinical Diagnostics has issued a recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CURVED-TIP STAPLER 30
The Issue: An increase in the number of da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAPLER 30
The Issue: An increase in the number of da Vinci
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIAISON Estradiol II Gen
The Issue: DiaSorin is issuing an urgent medical device correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition AS with software version VA48A-SP2
The Issue: Due to an internal communication error between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Flash with software version VA48A-SP2
The Issue: Due to an internal communication error between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Definition Edge with software version VA48A-SP2
The Issue: Due to an internal communication error between the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM
The Issue: The possibility exists for contaminants, in the form
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS ZEE AND ZEEGO
The Issue: The possibility exists for contaminants, in the form
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.