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 22721–22740 of 38,428 recalls
Recalled Item: STORZ High Flow Insufflation Tubing (with filter)
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert CT/NG Catalog GXCT/NG-120 Batch 1000049568
The Issue: Cepheid has received reports that some of our
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alteon HA Femoral Stem
The Issue: Wrong device description of the label identifying the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PURE OXYGEN CONCENTRATOR
The Issue: Post-market surveillance for Pure Stationary Oxygen Concentrators model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical 2 MHZ Waterproof OB Probe Product The CooperSurgical
The Issue: The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.p
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version
The Issue: Certain infusion pumps may exhibit excessive wear of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vial2BagDC
The Issue: Medimop is recalling certain lots of this product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiolucent Surgery Spine Frame (F70801). Surgical platform used to position
The Issue: The base of the frame has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allen Medical Bow Frame Model A-70800. Surgical platform used to
The Issue: The base of the frame has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Brilliance 64 computed tomography x-ray system
The Issue: Numerous issues related to software Brilliance iCT 4.1.6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ingenuity Core computed tomography x-ray system
The Issue: Numerous issues related to software Brilliance iCT 4.1.6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ingenuity CT computed tomography x-ray system
The Issue: Numerous issues related to software Brilliance iCT 4.1.6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Ingenuity Core 128 computed tomography x-ray system
The Issue: Numerous issues related to software Brilliance iCT 4.1.6
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults with BALLARD Technology WET
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Turbo-Cleaning Closed Suction System for Adults
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Turbo-Cleaning Closed Suction System for Adults
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.