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 19301–19320 of 38,428 recalls
Recalled Item: The LivaNova VNS Therapy System
The Issue: Lead impedance values reported by the affected VNS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ascension Modular Radial Head (MRH) Radial Head Implant
The Issue: The product was packaged with the Instructions for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presource Kit Total Joint Pack containing a double-wrapped basin component.
The Issue: The double wrapping of this custom kit basin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare 9805 and 9805P Hydraulic Patient Lifts
The Issue: Invacare has identified via customer complaints, the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revanesse Versa
The Issue: Labeling error. The product is labeled with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V-Twin
The Issue: During in-house testing it was determined that their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various GE Magnetic Resonance System on-site software version Product Usage:
The Issue: incorrect software version loaded
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroSet XT Injectable HA Bone Cement
The Issue: Incorrect expiry date of 17-Dec-19 Correct expiry date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroSet XT Injectable HA Bone Cement
The Issue: Incorrect expiry date of 9-Feb-20 Correct expiry date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xper Flex Cardio Physiomonitoring System
The Issue: There are 3 issues: 1) Under certain conditions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Long Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology
The Issue: The firm received consumer reports of the ceramic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lineum 4.35mm x 28mm Translation Screw
The Issue: Etching on the tulip head incorrectly states "24MM"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow CVC 2 Lumen
The Issue: The lidstock states the incorrect priming volume and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ddRCombi Plus FP
The Issue: A component of the device was recalled by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeoSpan SuperElastic Compression Staple w/Instruments
The Issue: The NeoSpan Compression Staple (10x10x10) kits from two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Staclot LA 20 () The Staclot¿ LA and Staclot¿
The Issue: There have been reports of shortened (T1-T2) results,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Staclot¿ LA () The Staclot¿ LA and Staclot¿ LA
The Issue: There have been reports of shortened (T1-T2) results,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Neurovascular
The Issue: Labeling error; 8F Balloon Guide Catheters have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.