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 27621–27640 of 38,428 recalls
Recalled Item: Dimension Vista Assays: Enzymatic Creatine (ECRE)
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advia Chemistry Assay: Lactate
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA CHEMISTRY ENZYMATIC CREATININE_2
The Issue: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen (TM) Laboratory Automation System configured with Thermo Scientific...
The Issue: The electrical cable that supplies power to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cygnus Medical First StepBedside ADDWATER Kit
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS)
The Issue: The firm received a customer complaint establishing that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona The Personalized Knee System Articular Surface Posterior Stabilized (PS)
The Issue: The firm received a customer complaint establishing that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PINNACLE¿ Introducer Sheath PINNACLE PRECISION ACCESS SYSTEM¿ Sheath...
The Issue: Terumo Medical is initiating this recall due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iVue and iVue 500 (now called iScan) OCT systems with
The Issue: A software anomaly was detected that affects Optovue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System (IS4000) user manual English and
The Issue: Intuitive Surgical has found that the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci S Surgical System (IS1200/IS2000/IS3000) user manual
The Issue: Intuitive Surgical has found that the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PTS Panels CHOL+HDL+GLU Test Strips
The Issue: This lot of test strips is showing an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare System X-ray Tomography Computed :
The Issue: It was discovered the patient support tabletop may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare System X-ray Tomography Computed :
The Issue: It was discovered the patient support tabletop may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare¿ Foot Section for Semi & Full Electric Beds
The Issue: The firm recently identified a quality issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare¿ Bariatric Bed with mattress and rails
The Issue: The firm recently identified a quality issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare¿ Bariatric Bed w/o mattress & rails
The Issue: The firm recently identified a quality issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Junction Boxes
The Issue: The firm recently identified a quality issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STAT-Check Resuscitation Bag Manual Emergency Resuscitation Bag with Carbon...
The Issue: Stat-check CO2 indicators are non-functional. The indicator is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF used with an
The Issue: New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.