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 11301–11320 of 38,428 recalls
Recalled Item: GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
The Issue: Stems may have an undersized spigot bore diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
The Issue: Stems may have an undersized spigot bore diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
The Issue: Stems may have an undersized spigot bore diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
The Issue: Stems may have an undersized spigot bore diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
The Issue: Stems may have an undersized spigot bore diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HawkOne Directional Atherectomy System
The Issue: Reports have been received of tip damage during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic HawkOne Directional Atherectomy System
The Issue: Reports have been received of tip damage during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LigaSure Blunt Tip Laparoscopic Sealer/Divider
The Issue: Customers reported that the device jaws were difficult
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m System
The Issue: There is a potential for abnormal (non-sigmoidal) amplification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m System
The Issue: There is a software issue associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m System
The Issue: There is a software defect that can cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m System
The Issue: There is an issue with the installation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker DARCO Screw
The Issue: The incorrect product is contained in the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ImagePilot Versions 1.92 and 1.93-software primarily facilitates processing...
The Issue: lmagePilot versions 1.92 and 1.93 paired with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker CLAW II ORTHOLOC 3DSi Plate
The Issue: The incorrect product is contained in the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wright Medical Technology Inc. CHARLOTTE MTP Hex Screw
The Issue: Incorrect product is contained in the packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vagus Nerve Stimulation (VNS) Therapy Leads
The Issue: A manufacturing issue may cause the silicone tubing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celltrion DiaTrust COVID-19 Ag Rapid Test
The Issue: Returned test kits were erroneously shipped to customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IPELA FHD PTZ TILE KITS with Axis cameras used in
The Issue: Tile kits that allow one to install and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Veradius Unity
The Issue: Firm discovered that the wireless foot switch can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.