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 7201–7220 of 38,428 recalls
Recalled Item: Centricity Universal Viewer Workflow Manager
The Issue: When using Universal Viewer or Centricity Universal Viewer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: F2-01 Frame
The Issue: There is a potential interruption of data communication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fogarty Thru-Lumen Embolectomy Catheter
The Issue: Inadvertent release of embolectomy catheters that may experience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom-Pak
The Issue: Custom surgical procedure packs contain latex gloves but
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Real Intelligence CORI RI.KNEE v2.0 TKA (Total Knee Arthroplasty) software
The Issue: CORI software was missing a planning stage that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RSP Glenoid Baseplate
The Issue: Coating hex did not engage with the Straight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AU/DxC AU Chemistry Transferrin Immune complexes formed in
The Issue: The firm has identified that the Transferrin reagent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Modena-IVD Clinical Chemistry Analyser Catalog Number: RX9000
The Issue: RX Parameter rerun settings (Sample Volume Low/High), and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Monaco-IVD Clinical Chemistry Analyser Catalog Number: RX5000
The Issue: RX Parameter rerun settings (Sample Volume Low/High), and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Imola-IVD Clinical Chemistry Analyzer Catalog Number: RX4900. RX4900R ()
The Issue: RX Parameter rerun settings (Sample Volume Low/High), and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Daytona Plus (with ISE)-IVD Clinical Chemistry Analyser Catalog Number:
The Issue: RX Parameter rerun settings (Sample Volume Low/High), and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041
The Issue: RX Parameter rerun settings (Sample Volume Low/High), and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin
The Issue: The complaint involved the absence of a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T HD SYS. W/O CDX BLUESTAR
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T Hemodialysis SYS
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T HD SYS. W/O CDX W/BIBAG BLUESTAR
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T Hemodialysis System w/Bibag
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T GEN 2 Bibag without CDX
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T HD SYS. CDX W/BIBAG BLUESTAR
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2008T Hemodialysis System without CDX
The Issue: PCBA leaching from tubing of hemodialysis machines
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.