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 31321–31340 of 38,428 recalls
Recalled Item: GE Healthcare Automatic Mobile X-Ray (AMX) Series: Brivo XR285amx
The Issue: An issue was identified with the mAs accuracy
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Electric Pen Drive (EPD) System
The Issue: In May 2013, the original recall was initiated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Focal Sim radiation therapy treatment planning system
The Issue: Incorrect CT to ED when using the Monaco
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monaco radiation therapy treatment planning system. The Monaco system is
The Issue: Incorrect CT to ED when using the Monaco
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Starburst MRI Semi-Flex Electrode Device
The Issue: Printed mark on the trocar intended to indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Crit Line in a Clip (CLiC) with SW version
The Issue: for misinterpretation of the graphic display of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The MAYFIELD¿ Ultra 360 Base Unit for head positioner
The Issue: Through an investigation of complaints, Integra found that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula
The Issue: The stopper of the 10mL BD Luer-Lok syringe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINAC Accelerators: ARTISTE
The Issue: A hardware update to replace the old PCB
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quickie Q7 Adult Rigid Wheelchair Model EIR4.
The Issue: There is the potential for the height adjustable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION
The Issue: The lot failed pH specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1.
The Issue: There is the potential for the height adjustable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD8 (Leu-2a) PE (In vitro diagnostic)
The Issue: One lot of CD8 PE is contaminated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anti-Lambda APC-H7
The Issue: Two lots of the Anti-Lambda APC-H7 antibody are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: lnline Persuader- PedFuse Pedicle Screw System
The Issue: A crack may develop in the handle to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Revolution CT.
The Issue: safety issue due to a required torque
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Cardiology ECG Management It is a software application designed
The Issue: An ECG procedure time stamp is incorrect, due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The XN-Series modules (XN-10
The Issue: There is a potential for elevated hemoglobin (Hgb)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas b 221 (versions 5 and 6) Blood Gas and Electrolytes Analyzer
The Issue: Chemical component of the F3 Fluid pack and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas 4800 KRAS AMP/DET 24T CE-IVD Mutation Test
The Issue: cobas KRAS Mutation Kit T10786 is generating invalid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.