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 24841–24860 of 38,428 recalls
Recalled Item: Mammotome Revolve Dual Vacuum Assist Biopsy System The device is
The Issue: The device did not have Revolve Stereo Probe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liebel-Flarsheim Direct Digital Imaging System (DDIS) Liebel-Flarsheim...
The Issue: Software issue. The difference between the display and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liebel-Flarsheim Hydra Vision Urology X-Ray System (DR) Liebel-Flarsheim...
The Issue: Software issue. The difference between the display and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTECH ROSA Spine 1.0.2 The device is intended for the
The Issue: Unapproved change made by the supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400
The Issue: A defective electrical component in the battery charging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDTECH ROSA Brain 3.0 The device is intended for the
The Issue: Unapproved change made by the supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft
The Issue: Medtronic is initiating a voluntary Urgent Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644
The Issue: Lot may contain the wrong instruction (Instruction for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q and Q.Zen fluoroscopic x-ray system
The Issue: A gap in the housing of the wireless
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Zee and Zeego fluoroscopic x-ray system
The Issue: A gap in the housing of the wireless
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axiom Artis fluoroscopic x-ray system
The Issue: A gap in the housing of the wireless
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascade Abrazo c-ACT-LR Test Card IVD FOR IN VITRO DIAGNOSTIC
The Issue: Due to some cards in this lot reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartStart MRx Monitor/Defibrillator
The Issue: HeartStart MRx Monitor/Defibrillator may may exhibit abnormal behavior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT model number 882482 BrightView and BrightView X are
The Issue: The brake hub was not engaging with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView X 3/4 model number 882479 BrightView and BrightView X
The Issue: The brake hub was not engaging with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView X 3/8 model number 882478 BrightView and BrightView X
The Issue: The brake hub was not engaging with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView SPECT model number 882480 BrightView and BrightView X are
The Issue: The brake hub was not engaging with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAMSHIDI NEEDLE BIOPSY [15G X 100MM DISP
The Issue: The integrity of the sterile packaging is potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thoracentesis/ Paracentesis Kit 10/CS
The Issue: The integrity of the sterile packaging is potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5
The Issue: The integrity of the sterile packaging is potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.