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 32441–32460 of 38,428 recalls
Recalled Item: Biomedix SELEC-3 I.V. Administration Set. Individually sealed into a Tyvek¿
The Issue: Customer contacted Biomedix of complaint and returned the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acrobat V Vacuum Off-Pump System OM-9100S Acrobat SUV Vacuum Off-Pump
The Issue: An internal finding identified the presence of pinholes/cuts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument is
The Issue: BioFire Defense, LLC is initiating a field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Disposable Patient Circuit that allows water to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Disposable Patient Circuit that allows water to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Disposable Patient Circuit that allows water to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Disposable Patient Circuit that allows water to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Water may leak into the center gas lumen
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ)
The Issue: Modification were made to the RENASYS EZ NPWT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Disposable Patient Circuit that allows water to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Disposable Patient Circuit that allows water to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vapotherm Precision Flow
The Issue: Disposable Patient Circuit that allows water to leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur XP Immunoassay System
The Issue: The firm is conducting a field correction for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano TrakBack II Disposable Pullback Device
The Issue: Internal testing had identified a potential breach to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Immunoassay System
The Issue: The firm is conducting a field correction for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V5Ms Transesophageal transducers
The Issue: Reports of deterioration of material covering the articulating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Siemens Symbia S series is intended for use by
The Issue: Siemens Medical Solutions USA, Inc. has received reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Siemens Symbia T series is intended for use by
The Issue: Siemens Medical Solutions USA, Inc. has received reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Symbia Intevo Excel is a non-diagnostic SPECT ICT system
The Issue: Siemens Medical Solutions USA, Inc. has received reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eXpertDC intraoral x-ray
The Issue: Two (2) failures of the spring link components
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.