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 14541–14560 of 38,428 recalls
Recalled Item: BRAINLAB Kick 2
The Issue: Incorrect manufacturer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BRAINLAB Curve
The Issue: Incorrect manufacturer calibration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system
The Issue: 1) 1) Potential intermittent issue may cause image
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx
The Issue: The therapy switch may fail, resulting in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: uMI 550 PET/CT Diagnostic Imaging System - Product Usage: This
The Issue: 1) Service function problem may cause false marking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibial knee prosthesis
The Issue: Due to an inconsistency in the raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pointts sistema de ellmlnact!
The Issue: Unit boxes not properly sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Personelle OTC Skin Tag Remover
The Issue: Unit boxes not properly sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVS Advanced Wart Remover Kit
The Issue: Unit boxes not properly sealed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Guardian Connect App CSS7200 iOS - Product Usage: intended
The Issue: As a result of the release of new
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SINGLES Carbide US-No. FG556
The Issue: US-dates between the product package label and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SICAT IMPLANT V2.0
The Issue: A dentist found implant positions are not correctly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA
The Issue: There is an increased rate of potential false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StimQ Peripheral Nerve Stimulator System (PNS) Models FR4A-SPR-BO US -
The Issue: The product contains a non-functional component not referenced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StimQ Peripheral Nerve Stimulator System (PNS) Model FR4A-TRL-AO US -
The Issue: The product contains a non-functional component not referenced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-RCV-AO US
The Issue: The product contains a non-functional component not referenced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US
The Issue: The product contains a non-functional component not referenced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StimQ Peripheral Nerve Stimulator System (PNS) Models: 1. FR4A-TRL-BO US
The Issue: The product contains a non-functional component not referenced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US -
The Issue: The product contains a non-functional component not referenced
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniTom Computed tomography x-ray system
The Issue: There are potential issues related to the operational
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.