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 34521–34540 of 38,428 recalls
Recalled Item: Trabecular Metal" Reverse Shoulder System
The Issue: As a result of complaints for disassociation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EPIQ 7 Ultrasound System
The Issue: A problem has been detected with Philips Model
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare qube Compact Patient Monitor
The Issue: Spacelabs Healthcare qube Compact Patient Monitor, Model 91390,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation
The Issue: Spacelabs Healthcare Ltd. of United Kingdom recalls ,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biotene Moisturizing Mouth Spray
The Issue: Label indicates, "Sweetened with xylitol and Sorbitol", however
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spacelabs Healthcare elance Vital Signs Monitor
The Issue: Spacelabs Healthcare elance Vital Signs Monitor with Option
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The HomeChoice Pro APD System is a peritoneal dialysis system.
The Issue: The occluder in affected devices 1) may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nanosphere Verigene Each CDF test consists of a Verigene CDF
The Issue: Nanosphere has received report of an increased rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bausch & Lomb AKREOS AO Micro Incision Lens The Akreos
The Issue: Lens was manufactured with incorrect raw material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay
The Issue: Microgenics Corp., part of Thermo Fisher Scientific, is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cutera brand truSculpt infrared System (optional)
The Issue: Cutera received two adverse events associated with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL90 FLEX Analyzer Radiometer Medical ApS
The Issue: RADIOMETER become aware that if the ABL90 FLEX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Radiology 12.0
The Issue: When merging two patient records into one patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Material Mix (Adjustable Cervical Distractor-Right
The Issue: One material batch used for production of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to
The Issue: Labeling inconsistency
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Multi Diagnost Eleva II
The Issue: The possibility of the Reference Air Kerma Rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Multi Diagnost Eleva with FlatDetector
The Issue: The possibility of the Reference Air Kerma Rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS TPSA
The Issue: Product is not approved or authorized for distribution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar Synthes 14.5
The Issue: Complaints were received reporting that a product packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips brand IntelliSpace PACS 4.4
The Issue: Philips Healthcare became aware of a software problem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.