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 1681–1700 of 38,428 recalls
Recalled Item: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product
The Issue: Knee implants contain incorrect labeling (size and/or side
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambu SPUR II Labeled as the following: 1 SPUR II Adult Resuscitator
The Issue: for the manometer port being blocked rendering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215.
The Issue: Label is incorrect. The product label indicates that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vercise Deep Brain Stimulation Systems Surgical Implant Manual
The Issue: Wire break(s) have occurred in rechargeable deep brain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Medline General Surgery Tray is customized to meet requirements
The Issue: Affected kits contain recalled Stryker Color Cuff Sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Burr Hole Cover Kit
The Issue: Resistance and difficulties could occur while closing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Trucount Controls
The Issue: Control kits contain incorrect standard deviation (SD) values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Trucount Controls
The Issue: Control kits contain incorrect standard deviation (SD) values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Pump Infusion Sets
The Issue: Infusion pump module used with compatible pump infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Pump Module Model
The Issue: Infusion pump module used with compatible pump infusion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent
The Issue: Certain batches are being removed due to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim
The Issue: an app defect that occurs when the phone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C5-2 Lumify Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S9-2 Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRANSDUCER L12-5 Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orascoptic Superior Visualization Dragonfly Essentials Kit ( Nose pad
The Issue: Due to complaints, loupe nose pads containing nickel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C6-2 Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L12-5 38mm Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C8-4v Transducer Probe
The Issue: To provide clarification and labelling to define the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.