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 10821–10840 of 38,428 recalls
Recalled Item: syngo.via RT Image Suite upgraded to VB60 running on syngo.via
The Issue: Upgraded software version makes an automatic change in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM
The Issue: Upgraded software version makes an automatic change in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo.via RT Image Suite upgraded to VB60 running on SOMATOM
The Issue: Upgraded software version makes an automatic change in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now
The Issue: Software error may result in sporadic problems causing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YSIO X.Pree
The Issue: For the automated multi-image-acquisition procedure Ortho x-ray collimation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
The Issue: The product was distributed without FDA authorization or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For
The Issue: Software issue resulting in temporary loss of central
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare MR Systems
The Issue: During the de-installation of an MR system magnet,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m HBV AMP Kit (US and CE)
The Issue: There is a potential for misquantitation high results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: First SIGN SARS-CoV-2 Antigen Test
The Issue: Frm became aware that a customer complaint was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Excelsior Medical 10mL Sterile Field Saline Flush ZR
The Issue: Sterility failure of the exterior of the syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m HBV Application Specification File (US and CE)
The Issue: There is a potential for misquantitation high results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VESSEL SEALER EXTEND
The Issue: Placing excessive tissue in the instrument jaws of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DAVINCI | Energy SynchroSeal da Vinci X' da Vinci Xi'
The Issue: Placing excessive tissue in the instrument jaws of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421
The Issue: Updated Instructions for Use (IFU) for EXALT Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Advanta V12 Covered Stent System (OUS only). Product Code/Part
The Issue: Firm has observed increased rate of customer complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iCast Covered Stent System Product Code/Part Number: 85400 85401 85402
The Issue: Firm has observed increased rate of customer complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420
The Issue: Updated Instructions for Use (IFU) for EXALT Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use:
The Issue: Updated Instructions for Use (IFU) for EXALT Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended
The Issue: Updated Instructions for Use (IFU) for EXALT Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.