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 15121–15140 of 38,428 recalls
Recalled Item: Dover 100% Silicone Foley Catheter with Temperature 16FR 5CC2W
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 100% Silicone Foley Catheter with Temperature Sensor 14FR 5CC2W
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 100% Silicone Premium Urine Meter Tray 400mL
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL
The Issue: Temperature sensing catheters failed to meet the established
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Samco Bio-Tite Sterile Specimen Container
The Issue: Product was not irradiated; therefore, they are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe Incubator with installed Servo Oxygen module. Infant incubator.
The Issue: for certain Giraffe Incubators and Giraffe OmniBeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe OmniBed with installed Servo Oxygen module. Infant incubator and warmer.
The Issue: for certain Giraffe Incubators and Giraffe OmniBeds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DDU-2450 Lifeline ECG Model Numbers DDU-A2450EN DDU-E2450DE DDU-E2450EN...
The Issue: A component issue may cause the AED to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DDU-2300 Lifeline/ReviveR View
The Issue: A component issue may cause the AED to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DDU-2400EN Lifeline PRO
The Issue: A component issue may cause the AED to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart MRx Monitor/Defibrillators Model numbers M3535A
The Issue: HeartStart XL MonitorlDefibrillators may not have been included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Skater Introducer Set 6F x 18cm. REF/UDI: 651506300/(01)00886333005000
The Issue: Tungsten coils of the guidewire included in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AngioDynamics NanoKnife Disposable Single Electrode Probes
The Issue: Programming issue affected RFID function of a single
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/
The Issue: The firm has identified through internal tests that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vein Irrigation Cannula with blunt tip. ASY VIC
The Issue: The firm has identified through internal tests that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/
The Issue: The firm has identified through internal tests that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/
The Issue: The firm has identified through internal tests that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/
The Issue: The firm has identified through internal tests that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X
The Issue: The firm has identified through internal tests that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/
The Issue: The firm has identified through internal tests that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.