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 16481–16500 of 38,428 recalls
Recalled Item: CS Elite Fastpack
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS5/5+ Bowl Kit-125 mL Autotransfusion Device - Product Usage: its
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS5/5+ Fastpacks
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAPAN CS ELITE FASTPACK
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Japan DISP SET
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS5/5+ Fastpacks
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS Elite Processing Set (125 ml) Autotransfusion Device - Product
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: High Speed Cell Saver¿5/5+ Bowl Set Autotransfusion Device - Product
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAPAN CELL SAVER ELITE SET - 125ML - Product Usage:
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAPAN BASIC HI SPEED CS5 SET
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JAPAN LOW VOL(125ML) CS5 SET
The Issue: to develop leaks at the inner core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System
The Issue: The 36 kHz Sterilization Tray (C7136 Rev C
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.