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 37221–37240 of 38,428 recalls
Recalled Item: Vital Signs Disposable General Purpose 9 French Temperature Probe For
The Issue: There is a potential for epistaxis during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw The
The Issue: Stryker has received reports from the field indicating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw The
The Issue: Stryker has received reports from the field indicating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian brand Eclipse Treatment Planning System
The Issue: Varian has identified an anomaly with the Eclipse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Octopus 101 Perimeter
The Issue: The firm recalled the device after learning of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KARL STORZ Photodynamic Diagnosis (PDD) D-Light C System
The Issue: The recall was initiated because Karl Storz has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll X Series Defibrillator/Pacemaker/Monitor Product Usage: The product is used
The Issue: Shipped with incorrect software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stockert Heater-Cooler 3T
The Issue: On August 15, 2012, Sorin informed consignees via
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.9% Sodium Chloride Injection
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: "***Sharpoint IQ Geometry Slit Knife Angled
The Issue: for bent tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: "***Sharpoint IQ Geometry Slit Knife Angled
The Issue: for bent tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: "***Sharpoint IQ Geometry Slit Knife Angled
The Issue: for bent tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: "***Sharpoint IQ Geometry Slit Knife Angled
The Issue: for bent tips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.9% Sodium Chloride Injection
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275
The Issue: Philips SureSigns VSi/VS2+ patient monitors may not be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THERA PEARL 3-in-1 BREAST THERAPY
The Issue: The Spanish translation on the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary...
The Issue: Creepage Distance between the two primary phases in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JUGGERKNOT IN¿GUIDE PUNCH
The Issue: Investigation found that the current design of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian brand Clinac
The Issue: Some X-jaw (lower collimator jaw) carriers were made
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.