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 33661–33680 of 38,428 recalls
Recalled Item: Sutures
The Issue: The products are being recalled because they did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5/10 Weck¿ Vista" Universal Balloon Open Access Port - Standard Length (70mm)
The Issue: Complaints were received of leakage of insufflation gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5/10/12 mm Weck¿ Vista" Universal Cannula
The Issue: Complaints were received of leakage of insufflation gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sutures
The Issue: The products are being recalled because they did
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nuclear gamma cameras (ADAC Vertex Plus
The Issue: Slippage of the radius drive belt in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra CUSA Excel Disposable Wrench. Catalog Number C5601. The CUSA
The Issue: Some 23 kHz Torque Wrenches were incorrectly assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed.
The Issue: The System may go into a controlled failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neusoft NeuViz 64 Multi-slice CT Scanner System
The Issue: The A-plane compensator is made of Teflon which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOVATION Femoral Stem
The Issue: The femoral stem is lacking specified plasma coating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Medical Solutions
The Issue: ACUSON P300 ultrasound systems using the PA230 transducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halogen Lamp component in RetCam 3 System - Clarity Medical Systems
The Issue: One lot of Halogen lamps have the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYM B Reagent (). The ZYM B reagent is
The Issue: bioMerieux identified a visual defect and activity issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API Listeria (). ZYM B reagent is used and
The Issue: bioMerieux identified a visual defect and activity issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FB Reagent (). FB reagent is an additional test
The Issue: bioMerieux identified a visual defect and activity issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API NIH (). ZYM B reagent is used and
The Issue: bioMerieux identified a visual defect and activity issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128
The Issue: A customer reported that after upgrading to software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia T and Symbia T2 computer tomography systems. These systems
The Issue: There are confirmed reports of a component coming
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DPM 6 Monitor in use with a Multi Parameter Module
The Issue: The MPM included a cardiac ST/Arrhythmia analysis feature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alfa Wassermann Diagnostic Technologies
The Issue: Extremely low absorbance readings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alfa Wassermann Diagnostic Technologies
The Issue: Extremely low absorbance readings
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.