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 20061–20080 of 38,428 recalls
Recalled Item: OptiView DAB IHC Detection Kit
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Air Optix Night & Day Aqua (lotrafilcon A)
The Issue: Potentially counterfeit products in/and counterfeit packaging were imported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module
The Issue: A software malfunction of the infuser when used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kerlix Bandage Roll
The Issue: for product sterility breach due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dermacea Gauze Fluff Roll
The Issue: for product sterility breach due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemosll ReadiPlasTin (10 mL Size)
The Issue: There is a potential for increased imprecision, out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kerlix Bandage Roll
The Issue: for product sterility breach due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dermacea Gauze Fluff Roll
The Issue: for product sterility breach due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kerlix AMD Antimicrobial Bandage Roll
The Issue: for product sterility breach due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kerlix Gauze Roll
The Issue: for product sterility breach due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIRO Mobile CT System Model # MobiCT-32
The Issue: The Tube Current Modulation feature (Modulated Scans) is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: sterEOS workstation
The Issue: 3D projections may be incorrect when the pair
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 (US)M
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOLOGIX AFX2 Bifurcated Endograft System
The Issue: Endologix is notifying physicians of patient tailored surveillance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 M ADULT ICU (CPM)
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20P (INTL) N W/PRINTER - ROHS
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20P (US) N W/PRINTER
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Capnostream20 (US) N W/PRINTER
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENDOLOGIX AFX/AFX2
The Issue: Endologix is notifying physicians of patient tailored surveillance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPNOSTREAM 20 (INTL) N W/PRINTER
The Issue: The date/time, nurse call and alarm settings of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.