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 19481–19500 of 38,428 recalls
Recalled Item: Zimmer Compress Devices and Instruments: Item Number/Item Description 178350...
The Issue: Correction to update the surgical technique for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE
The Issue: This recall has been initiated in response to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M200 Fall Monitoring System
The Issue: Damaged capacitor on the printed circuit board
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St. Jude Medical InfinityTM DBS System 8CH Directional Lead
The Issue: The most proximal unsegmented electrode of the Deep
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge
The Issue: Siemens Healthcare Diagnostics has confirmed that Dimension Vista
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer version 5.0.x with PACS-IW foundation
The Issue: Synchronization failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer with PACS-IW foundation 6.0.x displays medical...
The Issue: Synchronization failure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L5C4531 X1 Integrated APD Set with Cassette 3-Prong Sterile
The Issue: presence of leaks from the cassettes, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Naera Hospital Bassinet
The Issue: It was identified that the volume of air
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orthopedic Salvage System (OSS) Porous Stem
The Issue: Zimmer Biomet is conducting a lot specific medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive Mini Stem
The Issue: Zimmer Biomet is conducting a lot specific medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue MX40 Patient Monitor
The Issue: A problem has been detected in the Philips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart FR3 Defibrillator
The Issue: Automated external defibrillators may not fully meet IPx5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Theragenics Applicator Needle (18g x 20cm) The device is comprised
The Issue: Some of the pouches containing Brachytherapy Applicator Needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Granuflo Dry Acid Concentrate- 2K 2.0 Ca 1 Mg
The Issue: Discolored powder has confirmed the presence of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Granuflo Dry Acid Concentrate- 2K 2.5 Ca 1 Mg
The Issue: Discolored powder has confirmed the presence of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Granuflo Dry Acid Concentrate- 3K 2.5 Ca 1 Mg
The Issue: Discolored powder has confirmed the presence of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightMatter Guide
The Issue: This recall has been initiated due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Insulia Diabetes Management Companion
The Issue: The firm identified an issue with the basal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro
The Issue: VITROS Chemistry Products dLDL Reagent GENs 26 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.