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 20441–20460 of 38,428 recalls
Recalled Item: 2008T HEMODIALYSIS SYSTEM W/BIBAG
The Issue: In the hemodialysis machine during the cleaning/disinfection program,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T HEMODIALYSIS SYS
The Issue: In the hemodialysis machine during the cleaning/disinfection program,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial Alignment Guide
The Issue: Exactech is recalling the Tibial Alignment Guide because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Haemonetics OrthoPAT System-Integrated Set. Product Code: 1150H-00 OrthoPAT...
The Issue: OrthoPAT¿ reservoirs are missing the cannula inside the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Haemonetics¿ OrthoPAT¿ System-OPAT QuickConnect Reservoirs. Product Code:...
The Issue: OrthoPAT¿ reservoirs are missing the cannula inside the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VM 3/4/6/8 Patient Monitors
The Issue: Philips has received several reports in which monitors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VSV (Vital Signs Viewer)
The Issue: Philips has received several reports in which monitors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VS4 Vital Signs Monitor
The Issue: Philips has received several reports in which monitors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VS2 monitor
The Issue: Philips has received several reports in which monitors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VS3 Vital Signs Monitor
The Issue: Philips has received several reports in which monitors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Revolution CT systems with the SmartStep Option The system is
The Issue: On the Revolution CT systems equipped with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit
The Issue: Dental varnish has the possibility of having an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right
The Issue: Some sensors were reported to have fluid inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoSensor VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left
The Issue: Some sensors were reported to have fluid inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Right
The Issue: Some sensors were reported to have fluid inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right
The Issue: Some sensors were reported to have fluid inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left
The Issue: Some sensors were reported to have fluid inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OrthoSensor VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
The Issue: Some sensors were reported to have fluid inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products - Folate Reagent Pack(10758750009237) 1513266
The Issue: The recalling firm determined that biased results may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.