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 22361–22380 of 38,428 recalls
Recalled Item: IntelliVue X3 Patient Monitor.
The Issue: The NBP measurement of Intellivue X3 Patient Monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 241-McKesson Premium Skin Staple Remover Kit
The Issue: Product not meeting the iodine assay level requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: There is a risk of misalignment of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL DISPOSABLE PACK BONE-TENDON-BONE
The Issue: Routine bioburden testing of certain lots were found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRYKER WEDGE INTERFERENCE SCREW SYSTEM
The Issue: Routine bioburden testing of certain lots were found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRYKER CASSETTE PUMP
The Issue: Routine bioburden testing of certain lots were found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuikClot TraumaPad
The Issue: A customer complained that one of the pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: StrykeFlow 2 System
The Issue: Routine bioburden testing of certain lots were found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris PCA Pump
The Issue: The syringe plunger grippers may fail to automatically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris Syringe Pump
The Issue: The syringe plunger grippers may fail to automatically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoHDA(R) System
The Issue: Uncontrolled couch Z-axis movement (descent)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoH(R) System
The Issue: Uncontrolled couch Z-axis movement (descent)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoHD(R) System
The Issue: Uncontrolled couch Z-axis movement (descent)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hi-Art(R) System
The Issue: Uncontrolled couch Z-axis movement (descent)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALM XTEN Surgical Light intended to provide visible illumination for
The Issue: Getinge has received complaints concerning the X TEN
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brainlab Navigation System Spine & Trauma 3D with component Brainlab
The Issue: Due to a human error at a supplier,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM
The Issue: Complaint monitoring noted a trend of packaging being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated
The Issue: for cracked luer hubs
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spectra
The Issue: The Spectra System/Legacy Guided Surgery Handle Kit had
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Multi- Lumen CVC Kit
The Issue: Products do not contain the Central Venous Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.