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 22741–22760 of 38,428 recalls
Recalled Item: Halyard Turbo-Cleaning Closed Suction System for Adults
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard Closed Suction System for Adults
The Issue: Received recall notification from Smiths Medical that lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MONTERIS MEDICAL NEUROBLATE SYSTEM
The Issue: The firm received complaints that involved an unanticipated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Network Firewall (Cisco ASA 5506)
The Issue: Firewall installed with Philips IntelliVue Information Center iX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T
The Issue: While reviewing documentation for the next software release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WECK(R) from TELEFLEX Auto Endo5(R)
The Issue: The product has a non-conformity that may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DATEX-OHMEDA AISYS CS2 ALADIN2 CASSETTE Cassettes are intended to be
The Issue: Non-Conforming devices were shipped from the service center
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER Is designed for the metered
The Issue: Non-Conforming devices were shipped from the service center
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITY DUAL HEMO MCable Pod
The Issue: Dual Hemo MCable Pods with Revision Index (RI)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESONATE EL ICD VR
The Issue: The devices have an incorrect firmware configuration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESONATE X4 CRT-D
The Issue: The devices have an incorrect firmware configuration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOMENTUM X4 CRT-D
The Issue: The devices have an incorrect firmware configuration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RESONATE EL ICD DR
The Issue: The devices have an incorrect firmware configuration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIGILANT X4 CRT-D
The Issue: The devices have an incorrect firmware configuration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vygon IV Start Convenience Kits
The Issue: The Iodine Prep Pads within the Vygon IV
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard CR Porous Femoral 62.5mm (Left Femur) For use in
The Issue: The affected products are labeled as a 62.5mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Difco" Agar Noble
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sirus Drill 13mm diameter trauma instrument used for preparation of
The Issue: The Sirus Drill and Flexible Shaft instruments may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Shaft hip and anatomical shoulder instrument used for preparation
The Issue: The Sirus Drill and Flexible Shaft instruments may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Silicone Fluted Round Drain 24Fr (hubless) & Connector
The Issue: Sterile pouches are missing labels on them. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.