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 14981–15000 of 38,428 recalls
Recalled Item: RayStation 8B Service Pack 1
The Issue: Software error was identified in the Pencil Beam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250i
The Issue: Couch Correction moves sent after using a 3D
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3COR DISTRACTION SCREW
The Issue: Lack of pouch seal. Product is labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHANTOM CS DISTRACTION SCREW
The Issue: Lack of pouch seal. Product is labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHANTOM CS QUICK START DISTRACTION SCREW
The Issue: Lack of pouch seal. Product is labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHANTOM CS DISTRACTION SCREW
The Issue: Lack of pouch seal. Product is labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHANTOM CS QUICK START DISTRACTION SCREW
The Issue: Lack of pouch seal. Product is labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PHANTOM CS QUICK START DISTRACTION SCREW
The Issue: Lack of pouch seal. Product is labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3COR DISTRACTION SCREW
The Issue: Lack of pouch seal. Product is labelled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIRECT SUPPLY Attendant VITAL SIGNS MONITOR
The Issue: Failures were found in the temperature measurement function
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) CentraLink Data Management System software version 16.0.2 Siemens Material
The Issue: Unexpected interface driver behavior identified (QC) Results May
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer
The Issue: Flexible tubing connected to the liquid waste bottle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Atellica Data Manager software version 1.0 Siemens Material Number
The Issue: Unexpected interface driver behavior identified (QC) Results May
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry
The Issue: Flexible tubing connected to the liquid waste bottle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube
The Issue: Kit contained an incorrect catheter-tip syringe not compatible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM
The Issue: Distributed to the field without having completed design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm
The Issue: Distributed to the field without having completed design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.