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 19461–19480 of 38,428 recalls
Recalled Item: Argon Medical Devices Double Male LL Adapter
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices AHD Luer Lock Cap
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices Hemostasis Valve
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices Septishield II
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argon Medical Devices Plugs
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Argon Medical Devices Stopcocks
The Issue: The seal formed on the edge of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED EL Cochlear Implant System
The Issue: Devices were distributed despite the Helium-fine leak test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED EL Cochlear Implant System
The Issue: Devices were distributed despite the Helium-fine leak test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED EL Cochlear Implant System
The Issue: Devices were distributed despite the Helium-fine leak test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radrex-i X-Ray System (DRAD-3000E) TFP-4336W (Wireless FPD) Software...
The Issue: software malfunction; It was found when a user
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal Hip Replacement System
The Issue: The stage 1 and 2 reamer instruments used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 500
The Issue: Siemens Healthcare Diagnostics has identified an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 1500
The Issue: Siemens Healthcare Diagnostics has identified an issue with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xcela Power Injectable PICC with PASV (XCELA PASV 4F SL 55CM Catheter Kit CE PG)
The Issue: Specific lots of Xcela Power Injectable and BioFlo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO and PASV
The Issue: specific lots of Xcela Power Injectable and BioFlo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Family Wellness First Aid Sterile Gauze Pad 3 in x 3 in
The Issue: that gauze pads may not be fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion¿ Model 4000 Syringe Infusion Pump
The Issue: Customers who utilize PharmGuard¿ Server Software (PGS) with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jarvik 2000 Ventricular Assist System external components: JHI-212 Y Cable
The Issue: There is a potential for the male connectors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or
The Issue: Samples tested using ARCHITECT Free T3 or ARCHITECT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or
The Issue: Samples tested using ARCHITECT Free T3 or ARCHITECT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.