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 29561–29580 of 38,428 recalls
Recalled Item: Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking...
The Issue: The locking pin on the RIO Base Array
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiometer Fixation Kit N20 for the TCM CombiM monitoring system
The Issue: When the fixation ring is taken off the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Ventilator System
The Issue: Reports in which tidal volumes reaching patients were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate...
The Issue: Expansion of recall to lots manufactured in 2015
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a
The Issue: Otto Bock Healthcare GmbH is voluntarily recalling all
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine)
The Issue: Siemens has confirmed that the Dimension CREA and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049
The Issue: Iris International is recalling the iChemVELOCITY systems because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EnVeo R Loading System
The Issue: Medtronic is recalling the EnVeo R Loading Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Histolock Resection Device
The Issue: The company has determined the sterility cannot be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD
The Issue: Ortho Solutions Inc is initiating a recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas b 123 Fluid Pack COOX 400 Product
The Issue: Low PO2 results. QC failures of the PO2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas b 123 Fluid Pack COOX 200 Product
The Issue: Low PO2 results. QC failures of the PO2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT S(64)-4R
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 64-3R TruePoint w/ TrueV
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 6-4R TruePoint w/ TrueV
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph 64-4R TruePoint w/ TrueV
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT S(40)-4R
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYS IVK
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT Flow Edge-4R
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT X-4R
The Issue: Emission computed tomography systems and computed tomography xray
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.