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 20541–20560 of 38,428 recalls
Recalled Item: MAYFIELD Infinity XR2 Base Unit-Extended
The Issue: There is a potential for the knob assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation stand-alone software treatment planning system
The Issue: If the beam model has a highly asymmetric
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for
The Issue: The torque wrench used on the ceiling column
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Overhead Counterpoise Systems (OCS)
The Issue: The torque wrench used on the ceiling column
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Overhead Counterpoise Systems (OCS)
The Issue: The torque wrench used on the ceiling column
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Neonatal Flow Sensor Cable used on devices CARESCAPE R860
The Issue: The Neonatal Flow Sensor Cable may be missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Final Pack
The Issue: Sterile Wipes packed in these four Esteem II
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genicon EZee Single Use Specimen Retrieval Bag - Product Usage:
The Issue: Genicon is providing updated IFU labeling to users
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leksell GammaPlan 11.1 Product Usage: Leksell GammaPlan is a computer-based
The Issue: The margin tool in Leksell GammaPlan 11.1 systematically
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BACT/ALERT VIRTUO system
The Issue: The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BACT/ALERT VIRTUO system
The Issue: The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BACT/ALERT VIRTUO system
The Issue: The BACT/ALERT VIRTUO Instrument Firmware version R2.0 allows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BuckyDiagnost Ceiling System (Stitching Patient Support) 704031
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost Dual Detector (Stitching Patient Support) 712022
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasyDiagnost Eleva DRF (Stitching Patient Support) 706032
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost 4.1 High Performance (Stitching Patient Support) 712031
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost Single Detector (Stitching Patient Support) 712020
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost 4 Flex / Value (Stitching Patient Support) 712028
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost Release 3.1 (Stitching Patient Support) 712026
The Issue: The hook does not securely hold the footplate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.