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 10261–10280 of 38,428 recalls
Recalled Item: HAMILTON-C6 Intensive Care Ventilator
The Issue: Ventilator status indicator board can become loose, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System
The Issue: The device may potentially cause a fire, leading
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right
The Issue: The product was mispackaged (swapped). The devices within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Cholestech LDX¿ System combines enzymatic methodology and solidphase...
The Issue: Cholesterol test cassettes package insert is to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroLift System
The Issue: There is the potential that during implant deployment,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sprinter OTW
The Issue: Luer has balloon diameter printed as "2.25mmx12mm" instead
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker 2.3mm Tapered Router
The Issue: There is a potential for the core diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZEISS Axio Observer 5 microscope
The Issue: An incorrect Unique Device Identification (UDI) label was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Premier magnetic resonance scanner
The Issue: Under rare conditions, SIGNA Premier gradient coils could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
The Issue: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress
The Issue: The failure mode on the affected mattresses can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom PRO+ MRS Surface For Versacare With X-Ray mattress
The Issue: The failure mode on the affected mattresses can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom Centrella Pro+ 40" Surface mattress
The Issue: The failure mode on the affected mattresses can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
The Issue: Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom Centrella Pro+ 36" Surface mattress
The Issue: The failure mode on the affected mattresses can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom Centrella Pro+ 36" Surface With X-Ray mattress
The Issue: The failure mode on the affected mattresses can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom PRO+ MRS Surface For Versacare mattress
The Issue: The failure mode on the affected mattresses can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hill-Rom PRO+ 36" MRS Surface mattress
The Issue: The failure mode on the affected mattresses can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambra PACS
The Issue: A race condition between the storage system and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INOmax DSIR -(delivery system) delivers INOMAX (nitric oxide for inhalation)
The Issue: The INOmax DSIR Delivery System, manufactured by Mallinckrodt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.