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 10041–10060 of 38,428 recalls
Recalled Item: Artis pheno- Model No. 10849000
The Issue: Siemens has become aware of a potential hardware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dewei DNA/RNA Preservation Kit
The Issue: Products were distributed in the United States without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jiangsu Well Biotech Co.
The Issue: Distribution of COVID-19 Ag Rapid Test kits in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The BioZorb LP Marker is an implantable radiopaque marker used
The Issue: Hologic BioZorb LP Marker, (Product number F0221), lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter CLEARLINK System
The Issue: Firm noted an increase in customer reports of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Subdermal Needle Electrode
The Issue: Burns of varying degrees can occur to patients
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Guider Softip XF
The Issue: The impacted products were distributed with an MPXF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200
The Issue: Distribution of COVID Test Kits without FDA Approval,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PDS II (polydioxanone) Suture
The Issue: Product may contain the incorrect material which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker USB Converter
The Issue: Certain units have the potential to exhibit infant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINEAR 7.5Fr. 40cc IAB with Accessories (APA)
The Issue: The balloon volume is incorrectly described as 34cc
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
The Issue: Certain lots containing undersized dilator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
The Issue: Certain lots containing undersized dilator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
The Issue: Certain lots containing undersized dilator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LineSider Spinal System pedicle screws
The Issue: for intraoperative screw head separation at weld
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CorVocet Biopsy System/Catalog Code: CORA1610/B
The Issue: Biopsy Systems have components that are misaligned due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CorVocet Biopsy System
The Issue: Biopsy Systems have components that are misaligned due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker EVOLVE
The Issue: The outer label does not match the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker EVOLVE
The Issue: The outer label does not match the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Collagen Dental Wound Dressing - Bovine Dermis Tap
The Issue: The packaging may not be sealed, which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.