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 1181–1200 of 38,428 recalls
Recalled Item: Millenium MPS
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elscint Cardial
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maxicam
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima NX
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Workstation 5000
The Issue: Failure of Environmental Stress Testing from a pinched
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product: STA Liatest D-Di
The Issue: A potential risk of underestimation of D-Dimer (D-Di)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiac Workstation 7000
The Issue: Failure of Environmental Stress Testing from a pinched
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Excelsior Medical
The Issue: Medline has identified a limited quantity of saline
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iNSitu Bipolar Hip System
The Issue: Downstream recall for RES 97605, BioPro femoral components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FERNO POWER X2 POWERED AMBULANCE COT
The Issue: The fastening post hardware could loosen allowing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TENACIO Pump without InhibiZone
The Issue: The potential for devices to experience inflation and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150
The Issue: Additional IFU updates to provide further clarification on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.