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 26341–26360 of 38,428 recalls
Recalled Item: Syngo.plaza VB10A
The Issue: Software upgrade to eliminate several issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Monarch III (1) "C" Cartridge The device is used
The Issue: The intraocular lens could become lodged within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2000 Vascular with 30 Degree option
The Issue: for bed to drop suddenly at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Model 208-70-110
The Issue: Screws were identified as having the incorrect part
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD
The Issue: Labeling inconsistency
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756
The Issue: Error in the value assignment for the Chloride
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812
The Issue: Error in the value assignment for the Chloride
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITALE Silicon Foam Dressings 4"x4" Cat. No. 20144
The Issue: Adhesive border was not sticky enough
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visualase Visualization Stylets PN 020-2301. The individual components...
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visualase Body Accessory Kit PN 020-3000. The individual components within
The Issue: Medtronic Navigation, Inc. announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skintact Electrodes for Defibrillation
The Issue: There is a risk that defibrillation electrodes model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 2.5
The Issue: RaySearch became aware of the problem as it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 64 Multi-slice CT Scanner Systems
The Issue: The Firm discovered during contrast agent tracking scan,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuViz 128 Multi-slice CT Scanner System with software version 1.0.7.4038+P06
The Issue: The Firm discovered during contrast agent tracking scan,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sealapex Xpress
The Issue: SybronEndo is recalling the Sealapex Xpress because it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare SIGNA Creator
The Issue: GE Healthcare is conducting a recall dealing with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carry bar which is an accessory to a lift used
The Issue: The black plastic puck on the carry bar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay
The Issue: Multiple customers reported seeing an increase in imprecision
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay
The Issue: Multiple customers reported seeing an increase in imprecision
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier
The Issue: Medline Industries, Inc. supplies Navilyst with sterile package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.