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 35641–35660 of 38,428 recalls
Recalled Item: Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista
The Issue: There is the potential for the vial volume
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Endoscopic Flushing Pump
The Issue: There is a possibility that the pump head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERIS Fine Traction Device
The Issue: A bearing used in the assembly of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BASE
The Issue: The S-LIFT Instrument Case contained a bracket with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Code Alert Advanced 4-Way Care Solution
The Issue: RF Technologies, Inc. has initiated a recall involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device
The Issue: Power Superstand Standing Wheel chair, flex shaft (the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas Programmable Valve In Line Valve with Unitized BactiSeal
The Issue: Codman Certas Programmable Valves used for hydrocephalus may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas Programmable Valve In Line Valve with Siphonguard
The Issue: Codman Certas Programmable Valves used for hydrocephalus may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas Programmable Valve In Line Valve with SiphonGuard Device
The Issue: Codman Certas Programmable Valves used for hydrocephalus may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas Programmable Valve In Line Valve with SiphonGuard Device
The Issue: Codman Certas Programmable Valves used for hydrocephalus may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas Programmable Valve In Line Valve only with SiphonGuard
The Issue: Codman Certas Programmable Valves used for hydrocephalus may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas Programmable Valve In Line Valve with Catheter and
The Issue: Codman Certas Programmable Valves used for hydrocephalus may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Codman Certas Programmable Valve In Line Valve Only Product Code:
The Issue: Codman Certas Programmable Valves used for hydrocephalus may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
The Issue: to electrostatic discharged (ESD)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS Pro System The CoaguChek XS Pro System (CoaguChek
The Issue: Roche has confirmed the potential for an undetected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS System (PST) The CoaguChek XS PT test strips
The Issue: Roche has confirmed the potential for an undetected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS Plus System The CoaguChek XS Plus system for
The Issue: Roche has confirmed the potential for an undetected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoaguChek XS System (HCP) The CoaguChek XS System is intended
The Issue: Roche has confirmed the potential for an undetected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Soma v Automated Breast Ultrasound System (ABUS)
The Issue: Devices labeled for an intended use not included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blanketrol III Data Export Software Version 1.10 The Blanketrol III
The Issue: During a customer inquiry regarding a beta version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.