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 26481–26500 of 38,428 recalls
Recalled Item: Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Monitoring Kit with 30mL Flush Device
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TP4 Kit with 10cc SafeSet Reservoir
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Double Kit with SafeSet and 03mL Flush Device
The Issue: ICU Medical Inc. has identified a potential for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Cable. Part Numbers: 4460
The Issue: Blackrock Microsystems, LLC announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neural Signal Amplifier. Part Numbers: 4208
The Issue: Blackrock Microsystems, LLC announces a voluntary field action
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ddR Formula B X-ray System
The Issue: injury due to movement of the arm,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Number 3102071 Ceiling Bracket
The Issue: Ceiling Bracket 71 was shipped with a larger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Distal Femoral Augment 75 X 5 RL/LM Product Usage:
The Issue: Contents of the package do not match the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix Recon Targeting Arm Guide
The Issue: Old revisions and new revisions of the soft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Phoenix Recon Soft Tissue Sleeve Guide
The Issue: Old revisions and new revisions of the soft
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED 5223 - VacuFlow Safe
The Issue: The multi-sample needle retractable sheath may not fully
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
The Issue: The recalling firm identified ten devices which were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue
The Issue: The CPX4 Tissue Expander may have been packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders
The Issue: The CPX4 Tissue Expander may have been packaged
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ PSA Assay
The Issue: Communication provided to emphasize that the PSA values
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313
The Issue: Tissue expander product mix found: CPX4 350cc was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312
The Issue: Tissue expander product mix found: CPX4 350cc was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN
The Issue: Storage temperature listed on the label was incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD 23 G x .75 in. BD Vacutainer¿ Push Button
The Issue: BD has received multiple reports of units associated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.