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 29901–29920 of 38,428 recalls
Recalled Item: ATTUNE CONV RP CR ARTICULATION SURFACE SZ1
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The
The Issue: for the Balseal, a small wire spring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: A reported incident of a monitor that fell
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Precision 500D and Advantx Legacy/Legacy-D Radiographic and...
The Issue: The SFD/IDD safety mechanism may not engage properly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic DLP Femoral Arterial Cannula
The Issue: Medtronic is recalling select lots of DLP Femoral
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Etest Cefotaxime CT 256 WW and Etest Cefotaxime CT 256 US. in vitro diagnostic.
The Issue: QC results were out of range resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott
The Issue: The ARCHITECT c8000 instrument contains tubing that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JustRight 5mm Reload
The Issue: JustRight Surgical is recalling various lots of JustRight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNGO IMAGING (VERSION V30 and V31)
The Issue: During certain clinical workflows safety issues may occur
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JustRight 5mm Stapler
The Issue: JustRight Surgical is recalling various lots of JustRight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes
The Issue: Contain 0.1% Benzalkonium Chloride in the 5/8 bandages
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with
The Issue: There is a potential issue that could result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NDI Disposable Marker Spheres for Brainlab IGS (Image Guided
The Issue: Inadequate curing of adhesive, may cause the two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA)
The Issue: The height of one of the three guiding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Offset Femoral Alignment Guide 4mm x 6¿
The Issue: The markings on both versions of the OFFSET
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Offset Femoral Alignment Guide
The Issue: The markings on both versions of the OFFSET
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Scientific Solutions Americas Analytical X-ray System. Delta
The Issue: Higher than published scatter around the probe head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide
The Issue: Inadequate interference between the screw and the plate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle Re-sterilizable Breast Implant Sizer
The Issue: Allergan is recalling the NATRELLE 410cc Re-Sterilizable Breast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart...
The Issue: Multiple software and hardware issues with device that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.