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 10141–10160 of 38,428 recalls
Recalled Item: Hobbs Posi-Stop Injection Needle Catalog Number: 4712
The Issue: Device label display an incorrect expiration date, extends
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freeman Pancreatic Flexi-Stent Catalog Number: 6566
The Issue: Device label display an incorrect expiration date, extends
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diasol Acid Concentrate 100
The Issue: Due to labeling issue. The box label is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T and 2008TBluestar Hemodialysis Machines with CDX-Indicated for acute and
The Issue: (1)Software version 2.74 upgrade and (2)hardware related cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barco Medical Network Adapter
The Issue: installation issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORCA FOAM STANDARD CUBE 10x10x10 mm
The Issue: In routine bioburden testing, higher than acceptable levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helix Elite Inactivated Standard
The Issue: Product not registered for use in the UK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone
The Issue: An incorrect sizing label was applied to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified...
The Issue: Acidified Concentrate Distribution System potential electrical safety hazard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
The Issue: Products were released to customers prior to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT STAT Troponin-I Reagent Kit
The Issue: One lot of reagent was manufactured with insufficient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta Clinician Programmer Application
The Issue: communication issue in which the Vanta Clinician
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta Clinician Programmer Application
The Issue: for Vanta Clinician Programmer Application (CP App)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
The Issue: Due to the presence of a burr which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"
The Issue: The sterile barrier may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NARMD MEDICAL DEPOT Forceps - Kelly Curved 5.5"
The Issue: The sterile barrier may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NARMD MEDICAL DEPOT Scissors Iris Curved 4.5"
The Issue: The sterile barrier may be compromised
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEQ-HLS 5050 USA
The Issue: The firm has expanded the recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEQ-HLS 7050 USA
The Issue: The firm has expanded the recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEQ-HLS 7050 USA
The Issue: The firm has expanded the recall for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.