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 22761–22780 of 38,428 recalls
Recalled Item: iBalance(R) UKA
The Issue: Arthrex part number AR-501-UFLC, size 3, batch 10123297,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Go.Up computed tomography (CT) x-ray system table
The Issue: The table may become unstable if the nuts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Go.Now computed tomography (CT) x-ray system table
The Issue: The table may become unstable if the nuts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemosphere System with the following three components: HEM1 Advanced Monitor
The Issue: Pre-procedural issues related to software defects
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUIOS CL Flow Cytometer
The Issue: The system may duplicate sample requests leading to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accutest Drug Test Cup 5+3 Product Usage: The Accutest Drug
The Issue: Product was released to market without the adulteration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm¿ O2 interventional fluoroscopic x-ray system
The Issue: During servicing of certain internal components of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaturaLyte¿ Liquid Acid Concentrate 2.0 mEq/L
The Issue: The label specifies the potassium concentration is 2.0
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Complete Knee System
The Issue: Knee implant components (tibial bearings) are labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanguard Complete Knee System
The Issue: Knee implant components (tibial bearings) are labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD UROS AUTOMATED URINE OUPTUT AND TEMPERATURE MONITOR
The Issue: The possibility exists that use of the Uros
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSCILLATING SAW ATTACHMENT Surgical instrument motors and...
The Issue: This voluntary recall was initiated because a veterinary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT c4000 part number 02P24
The Issue: The Peristaltic Head tubing placed on the ARCHITECT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tubing
The Issue: The Peristaltic Head tubing placed on the ARCHITECT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an
The Issue: The firm has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magstim Rapid Therapy System consisting of: Rapid Mainframe
The Issue: Users manuals not supplied with 4800-00T US Rapid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cosmedent's Etching Gel
The Issue: Product packaged in a syringe that is not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless
The Issue: The possibility exists for the wireless foot switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee and Artis zeego model Interventional fluoroscopic x-ray foot
The Issue: The possibility exists for the wireless foot switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V-PRO 60 Low Temperature Sterilization System (UDI: 00724995152000)
The Issue: Correction to update sterilizer software to prohibit the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.