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 8321–8340 of 38,428 recalls
Recalled Item: Smith&Nephew ENGAGE Cementless Partial Knee System
The Issue: Recent complaint data indicates that the revision rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith&Nephew ENGAGE Cementless Partial Knee System
The Issue: Recent complaint data indicates that the revision rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith&Nephew ENGAGE Cementless Partial Knee System
The Issue: Recent complaint data indicates that the revision rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smith&Nephew ENGAGE Cementless Partial Knee System
The Issue: Recent complaint data indicates that the revision rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phadia 2500EE instrument -Intended for the in vitro semi-quantitative...
The Issue: Higher reported results when running EliA GliadinDP IgG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EliA GliadinDP IgG Well in the Phadia 2500EE instrument (Material
The Issue: Higher reported results when running EliA GliadinDP IgG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo O2 EV300
The Issue: Environmental debris may accumulate on the internal machine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B
The Issue: IFU- Instructions for Use (IFU) package insert and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo
The Issue: Environmental debris may accumulate on the internal machine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo Universal Ventilator
The Issue: The Trilogy Evo Universal ventilator provides continuous or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo O2 and LifeVent EVO2
The Issue: Environmental debris may accumulate on the internal machine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time...
The Issue: Faulty cartridges in the lot could result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex HORIZON Microclip Titanium Ligating Clips w/tape
The Issue: Teleflex LLC is initiating this voluntary field corrective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intelli-C
The Issue: There is a potential that the drive shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intelli-C
The Issue: There is a potential that the drive shaft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRI Biomet Pin Guide for Total Knee Arthroplasty (Zimmer Biomet
The Issue: The wrong tibia guide was included intended for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartSine
The Issue: Single use battery and electrode cartridge may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 &...
The Issue: The firm has identified an increased risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146
The Issue: Metal mounting box on the rotating scanner on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Incisive CT-Computed Tomography X-Ray System Model: 728143
The Issue: Metal mounting box on the rotating scanner on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.