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 4101–4120 of 38,428 recalls
Recalled Item: Ziehm Solo FD. Interventional fluoroscopic x-ray system
The Issue: Ziehm Imaging, Inc., distributor, have been informed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision RFD. Interventional fluoroscopic x-ray system
The Issue: Ziehm Imaging, Inc., distributor, have been informed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision system
The Issue: Ziehm Imaging, Inc., distributor, have been informed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision R. Iterventional fluoroscopic x-ray system
The Issue: Ziehm Imaging, Inc., distributor, have been informed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision RFD 3D. Interventinoal fluoroscopic x-ray system
The Issue: Ziehm Imaging, Inc., distributor, have been informed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ziehm Vision FD. Interventional fluoroscopic x-ray system
The Issue: Ziehm Imaging, Inc., distributor, have been informed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fusion Pro 24
The Issue: a. A small number of Fusion Pro 24
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DAILIES TOTAL1
The Issue: Material with a quality issue was used in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system...
The Issue: Firm has developed a software correction (Revision D.00)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system...
The Issue: Firm has developed a software correction (Revision D.00)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system...
The Issue: Firm has developed a software correction (Revision D.01)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eakin Cohesive seal
The Issue: On lot of cartons of Eakin Cohesive small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system...
The Issue: Firm has developed a software correction (Revision D.01)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViewPoint 6
The Issue: The National Institute of Standards and Technology (NIST)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifold
The Issue: for product leakage from the Spin Lock
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ViewPoint
The Issue: The National Institute of Standards and Technology (NIST)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biolox Option Taper Sleeve
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Pressure Module BPM3 TM-2917B (Spare Part Numbers 191378 or
The Issue: Machines equipped with BPM3 Blood Pressure Modules (Blood
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biolox Option Taper Sleeve
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic
The Issue: A half-threaded bolt was included in the LTE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.