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 32661–32680 of 38,428 recalls
Recalled Item: QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is
The Issue: The QLAB a2DQ and aCMQ features have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI
The Issue: The temperature probe does not properly connect to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI
The Issue: The temperature probe does not properly connect to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is
The Issue: The QLAB a2DQ and aCMQ features have a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters
The Issue: Integra LifeSciences is recalling the Camino Intracranial Pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical Systems Allura Xper FD20C with software version R8.2.O
The Issue: Faulty Automatic Motion Controller (AMC), a problem in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Medical Systems Allura Xper FD20C Radiological Imaging with software
The Issue: Faulty Automatic Motion Controller (AMC), a problem in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus ACMI Falope-Ring Dilator
The Issue: Falope-Ring Dilator for Reusable Falope-Ring Band Applicators have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Specialty Aria Inserter
The Issue: Stryker has initiated the recall of its Aria
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Luminos dRF
The Issue: It was discovered that during a RAD examination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Aria Implant Inserter
The Issue: Stryker has initiated the recall of its Aria
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: sound loss associated with the CARESCAPE Monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H4051 Endo Tube Holder
The Issue: The tube fastener on the ET Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy
The Issue: The tube fastener on the ET Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H4052 Endo Tube Holder
The Issue: The tube fastener on the ET Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy
The Issue: The tube fastener on the ET Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy
The Issue: The tube fastener on the ET Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy
The Issue: The tube fastener on the ET Tube Holder
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System (VITROS 5
The Issue: Ortho Clinical Diagnostics has identified an anomaly with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System --- For use in the in vitro quantitative
The Issue: Ortho Clinical Diagnostics has identified an anomaly with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.