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 31881–31900 of 38,428 recalls
Recalled Item: Glucose Hexokinase (Liquid) Reagent For the in vitro quantitative determination
The Issue: Product is not performing according to specifications. Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Titanium Polyaxial Reduction Head for Titanium Matrix Spine Screws:
The Issue: Two nonconforming parts of the Titanium Polyaxial Reduction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Legionella Latex Test
The Issue: A reagent within the test may return false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott m2000sp
The Issue: Some versions of Application Specifications (App Spec) are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Legionella Pneumo Groups 2-14 Latex Test
The Issue: A reagent within the test may return false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Expression MR200 MRI Patient Monitoring System.
The Issue: The MR 200 devices failed the initial power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gateway OTW 2.75mm x 9mm
The Issue: Units of GDC 360 coils, Target coil and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GDC-10 360 SOFT 3mm x 6cm SR
The Issue: Units of GDC 360 coils, Target coil and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GDC-10 360 10mm x 30cm SR
The Issue: Units of GDC 360 coils, Target coil and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GDC-18 360 20mm x 33cm
The Issue: Units of GDC 360 coils, Target coil and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Target 360 Standard 12mm x 30cm
The Issue: Units of GDC 360 coils, Target coil and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HomeChoice/HomeChoice Pro Automated Personal Cycler
The Issue: The keypad buttons on HomeChoice devices may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. and
The Issue: All packages of Falope Ring Band Applicator kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The MectaLIF Oblique Handle
The Issue: The MectaLIF Oblique Handle has the laser marking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit
The Issue: A gel-like substance was found in kit component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diamedix Is-EBV-VCA IgG Test Kit Diamedix Is-Mumps IgG Test Kit
The Issue: A gel-like substance was found in kit component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diamedix Is-EBV-EA-D IgG Test Kit Diamedix Is-Mumps IgG Test Kit
The Issue: A gel-like substance was found in kit component,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemoCue¿ Glucose 201 Microcuvettes
The Issue: Batches of HemoCue Glucose 201 Microcuvettes show discoloration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoracentesis & Paracentesis Procedure Tray
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rapid Centesis Catheter
The Issue: PFM Medical is recalling catheters and other medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.