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 12821–12840 of 38,428 recalls
Recalled Item: ZVplasty Biopsy Device
The Issue: Products distributed as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerPort duo M.R.I. Implantable Port
The Issue: Catheters may experience difficulty in flushing, infusion, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerPort duo M.R.I. Implantable Port
The Issue: Catheters may experience difficulty in flushing, infusion, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PowerPort duo M.R.I. Implantable Port
The Issue: Catheters may experience difficulty in flushing, infusion, and/or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intellis Model 97755 Recharger - Product Usage: designed to charge
The Issue: There is a potential for unintended heating that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas Liat Analyzer: respiratory virus panel nucleic acid assay system
The Issue: Invalid or false positive results for one or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents
The Issue: Invalid or false positive results for one or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Model Number: (9A)9.0.0.113
The Issue: Flags edited in RayCare after a patient has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aftermarket Alaris Infusion Pump Module Model 8100 Front Bezel
The Issue: Aftermarket front bezel components were installed during service/repair,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended
The Issue: BioGX SARS-CoV-2 Reagents for BD MAX" System rehydration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drop Arm Versamode"
The Issue: The front casters on the 6810A Lumex Drop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bioseal
The Issue: Pre-op skin prep component ChloraPrep included within kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bioseal
The Issue: Pre-op skin prep component ChloraPrep included within kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bioseal
The Issue: Pre-op skin prep component ChloraPrep included within kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VenaSeal Closure System
The Issue: Firm received increased number of reports that VenaSeal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Tri-Staple 2.0 Reinforced Intelligent Reload 60 mm Medium/Thick-For use
The Issue: for the pouch to contain an extra
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUNSTAR Butler Clear Dip
The Issue: Product may be contaminated with Burkholderia contaminans
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips SureSigns VM4
The Issue: Fail to Comply with Chinese Standard YY1079-2008: Clauses
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectrum Medical Quantum Standard heat exchanger
The Issue: Product labeled as sterile may not have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Normand Remisol Advance Data Manager is a software device that
The Issue: Instructions For Use for software versions 1.5 to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.