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 38181–38200 of 38,428 recalls
Recalled Item: Boule Con-Diff Hematology Control For in vitro diagnostic use as
The Issue: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boule Con-Diff Hematology Control For in vitro diagnostic use as
The Issue: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boule Con-Diff Hematology Control For in vitro diagnostic use as
The Issue: Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant
The Issue: Stryker Spine has received six reports regarding the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbiq Two Channel Infuser
The Issue: May go to a white screen due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbiq One Channel Infuser
The Issue: May go to a white screen due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LANX
The Issue: Biomet Spine, LLC. announces voluntary recall of Durango
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT
The Issue: The DoseRight feature suggest a mAs based on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Imagecast PACS is an image management system intended to be
The Issue: In Imagecast PACS versions prior to 3.6.51.01, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ****** 3mm Diamond Ball. Used for cutting and shaping bone.
The Issue: Due to three batches of product may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mini-Infuser Model 150XL Single Speed Infusion Pump
The Issue: Should a battery with the minimum contact diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mini-Infuser Model 300XL Multispeed Infusion Pump
The Issue: Should a battery with the minimum contact diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance 64 Computed Tomography X-Ray System
The Issue: Multiple software defects which could impact the performance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog...
The Issue: Defect in the luer connector can compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852...
The Issue: Defect in the luer connector can compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass
The Issue: Defect in the luer connector can compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The
The Issue: Defect in the luer connector can compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits
The Issue: Defect in the luer connector can compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage:
The Issue: Defect in the luer connector can compromise the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: Exposed high voltage wires inside the cabinet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.