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 29181–29200 of 38,428 recalls
Recalled Item: VITROS Chemistry Products Calibrator Kit 9 Calibrator
The Issue: The firm is conducting a product correction due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIA Radiation Oncology
The Issue: An anomaly was identified with the ARIA for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes 2.7MM/3.5MM VA-LCP Medial Distal Humerus Plates 10H/RT/186mm-...
The Issue: The 2.7MM/3.5MM VA-LCP Humerus Plates were found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 640G
The Issue: The pump drive motors may experience a malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniMed 620G
The Issue: The pump drive motors may experience a malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Radius 5.5 to 3.5 Rod to Red Connector
The Issue: Stryker Spine is recalling Radius Rod to Rod
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODULARIS VARIOSTAR
The Issue: Display freeze of MODULARIS hand control results in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Airways Development LLC WaterPAP Positive Airway Pressure Device #WP-7700.
The Issue: Airways Development LLC has received a complaint about
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Hemoglobin A1c_3
The Issue: Reagent in these lots may demonstrate an increased
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARMONIC ACE+ 7 Laparoscopic Shears with Advanced Hemostasis (23cm
The Issue: Complaints of holes in Tyvek which can compromise
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventilator Tubing
The Issue: As a distributor of tubing manufactured by Smooth
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR Surgical Suite II Table
The Issue: GE became aware of an issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novation Element Press-Fit
The Issue: Eight (8) pieces did not receive the specified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature Patient-Specific Surgical Guides
The Issue: inaccuracies in the alignment of the guides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TELETOM EQUIPMENT MANAGEMENT SYSTEM 4 and 6 series TELETOM is
The Issue: During the use of the TELETOM Series 4
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software with Issuer of Patient ID (IPID). The
The Issue: For sites using the Issuer of Patient ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Cardio software. Product Usage: Merge Cardio is a system
The Issue: Users can merge a device import file with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling
The Issue: for sample tubes in the loader to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELITech Clinical Systems reagents used on the Selectra ProS and
The Issue: ELITech Clinical Systems reagents based on Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eon 100 system included the following product numbers and
The Issue: ELITech clinical Systems reagents based on Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.