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 35541–35560 of 38,428 recalls
Recalled Item: 5.0mm Unit Rod 270mm 5.0mm Unit Rod 290mm 5.0mm Unit
The Issue: DePuy Synthes has issued a Medical Device Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass
The Issue: Siemens Healthcare Diagnostics has received complaints that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axiom Aristos MX Solid State Flat Panel Digital Imager
The Issue: Siemens issued a Field Safety Notice about the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an...
The Issue: Over-Pressure Safety Valves not cleared with an indication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare Power Wheelchair
The Issue: Unintended slowing or deceleration, and on rare occasion,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mesa Smart-Read EZTEST BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use
The Issue: Self-contained steam biological indicator, are recalled because Mesa
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mesa EZtest BIOLOGICAL INDICATOR MONITORING SYSTEM. Intended for use in
The Issue: Mesa EZTest , Self-contained steam biological indicator, are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ExactaMix 1200 and 2400 Compounders. Used as an automated pumping
The Issue: Baxter Healthcare is recalling certain ExactaMix automated compounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respironics V60 Ventilator
The Issue: Respironics California, Inc. has initiated a recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Deltran Disposable Pressure Transducer Kit (DPT Kit) Extracorporeal...
The Issue: Utah Medical Products, Inc. is recalling certain Deltran
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Brand Name(s): Innovacon Oral Fluid Drug Screen Device
The Issue: Alere initiated this recall of certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream DRX Evolution System
The Issue: Due to potential for an x-ray exposure technique
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AU5800 Clinical Chemistry Analyzer with Automation Ready Connection (All...
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216
The Issue: Cassette may leak during set up or during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Intrathecal Catheter
The Issue: The Sutureless Connector (SC) Intrathecal Catheter connector has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Sutureless Pump Connector Revision Kit
The Issue: The Sutureless Connector (SC) Intrathecal Catheter connector has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed II
The Issue: Medtronic Neuromodulation is providing Healthcare Providers with safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Intrathecal Catheter Pump Segment Revision Kit
The Issue: The Sutureless Connector (SC) Intrathecal Catheter connector has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed EL Programmable pumps
The Issue: Medtronic is providing Healthcare Professionals with important safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SynchroMed II
The Issue: Medtronic is providing Healthcare Professionals with important safety
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.