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 17721–17740 of 38,428 recalls
Recalled Item: Hudson RCI Sheridan: 1) Uncuffed 6.0 mm
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Obalon Balloon System with Model 4300 Touch Dispenser Touchscreen
The Issue: During initial set-up and/or replacement of the dispenser
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various products which were contract sterilized.
The Issue: The contract sterilizer did not have adequate packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DOSI-FUSER 12591 5-500D1 -USA
The Issue: The product lacks 510(k) clearance, and therefore is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: E-Line Cutting Electrode 11.5Fr Mono 0 degrees
The Issue: E-Line Cutting Electrode package 8416.0305 contains E-Line Hook
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: "HEMOGLOBIN A1c CALIBRATORS *** *** 307261/R03 *** S4P5X0
The Issue: Calibrator level 2 bottle may have been manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1
The Issue: There is a potential that one or more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The device is a 25-gauge infusion line that is part
The Issue: Labeled 25-gauge surgical pack, TDC Vitrectomy Pack VGPC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Alinity ci-series System Control Modules which are configured with
The Issue: All versions of the Alinity ci-series software may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRG Salivary Testosterone ELISA- IVD for the detection of Testerone
The Issue: Salivary assay may observe a higher percentage of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hancock II T510 Bioprosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mosaic 310 Bioprosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mosaic 310 Bioprosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hancock II T510 Bioprosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hancock II T510 Bioprosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LVivo EF app on Vscan Extend. Sold under the following
The Issue: Overestimation bias in automatically calculated ejection fraction (EF)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C
The Issue: Customers using the firm's continuous glucose monitoring system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Visibly Online Vision Test which is part of
The Issue: Lack of 510K clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product...
The Issue: Possibility that inlet pump hose of the Washer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product...
The Issue: Possibility that inlet pump hose of the Washer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.