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 13181–13200 of 38,428 recalls
Recalled Item: VITEK 2 Compact (version numbers 8.01
The Issue: bioM¿rieux has identified a potential safety risk worst
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit - Product Usage: Used for Continuous Renal
The Issue: Variability in the performance of the tubing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Preventative Maintenance Kits G5010007) and spare part kits (G5064801 and
The Issue: Variability in the performance of the tubing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 (version numbers 8.01
The Issue: bioM¿rieux has identified a potential safety risk worst
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prismaflex Control Unit - Product Usage: Used for Continuous Renal
The Issue: Variability in the performance of the tubing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TECNIS Toric 1-Piece IOL
The Issue: Due to the release of nonconforming Intraocular Lenses
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis / Sensis Vibe systems with software version VD12 and
The Issue: System may sporadically freeze (lock-up) during operation or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gram-Negative Bacteria And Associated Resistance Markers
The Issue: The firm has identified an increased risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFire BCID2 Panel
The Issue: The firm has identified an increased risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14
The Issue: The size indicated on the labeling on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER.
The Issue: The size indicated on the labeling on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RNA MEDICAL
The Issue: Product was compromised during shipment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digitial Medica X-ray Imagining System
The Issue: There is a potential for the X-Ray tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Open Heart Pack
The Issue: Sternum saw blades within procedure packs are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CV Basin Set Pack
The Issue: Sternum saw blades within procedure packs are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heart Pack
The Issue: Sternum saw blades within procedure packs are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiation therapy software
The Issue: A software bug affecting results when using deep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular...
The Issue: Test results from the manufacturing line found a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barco MDNC-3421 DISPLAY
The Issue: A number of MDNC-3421 displays were shipped while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Band
The Issue: The text on the patient pack is correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.