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 31341–31360 of 38,428 recalls
Recalled Item: Merlin@home RF Remote Monitoring Transmitter
The Issue: Transmitter may initiate a software reset resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femto LDV Z-Generation Femtosecond Surgical Lasers are used to perform
The Issue: The devices were not shipped with the Starter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ti-Bond Marketing Literature/Labeling
The Issue: Spinal Elements is recalling the Ti-Bond related brochures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Apollo (cold) Laser Desktop Control Units
The Issue: Control units were equipped with an internal mounting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoCr Femoral Head - A modular head component is used
The Issue: compromise of the inner sterile tray. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metasul Femoral Head - indicated for total hip arthroplasty for
The Issue: compromise of the inner sterile tray. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Metasul Femoral Head - A modular head component is used
The Issue: compromise of the inner sterile tray. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoCr Femoral Head - indicated for hip arthroplasty for noncemented
The Issue: compromise of the inner sterile tray. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biolox Delta Femoral Head - The BIOLOX delta Ceramic Femoral
The Issue: compromise of the inner sterile tray. If
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block
The Issue: for implant deformation, implant mechanical stability too
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants
The Issue: for implant deformation, implant mechanical stability too
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm
The Issue: for implant damage, implant cracking off/breaking intra-operatively
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB)
The Issue: Article #81036 (MEDPOR Titan Max OFW - MTB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Miethke Shunt System accessories Product Usage: - The Miethke Shunt
The Issue: Some Miethke Shunt System accessories may have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Anaerobic Pulsator Arterial Blood Sampling Kit
The Issue: The outer box label is marked with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform
The Issue: The staining intensity decreases over the shelf life
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump
The Issue: Ferrule Cap was not removed on some fiber-optic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASSY
The Issue: Unqualified power assemblies shipped to customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR
The Issue: the Instructions for Use (IFU) were inadvertently removed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry XPT interfaced to the CentraLink Data Management System
The Issue: Enabling sending of preliminary/initial results on the ADVIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.