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 27981–28000 of 38,428 recalls
Recalled Item: RadSuite software. The firm name on the label is Merge Healthcare
The Issue: Interventional Radiology (IR) images are stored as JPEG2k
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iConnect Access used with Merge PACS software provides medical specialists
The Issue: Studies that are viewed in iConnect Access that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iConnect Access used with Ortho PACS software provides medical specialists
The Issue: Studies that are viewed in iConnect Access that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. Product was distributed under the AMICAS label
The Issue: The patient name in the Halo title bar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. The firm name on the label is Merge Healthcare
The Issue: Studies coming over via telmed were missing patient's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge PACS software. The firm name on the label is Merge Healthcare
The Issue: A migrated study that has annotations will display
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge OfficePACS software. The firm name on the label is Merge Healthcare
The Issue: data loss occurs as a result of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orapharma (Onpharma) Onset Mixing Pen Rx only
The Issue: It has been determined that the Onset Mixing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinity Acetabular Shell Product Usage Total Hip Replacement.
The Issue: for abrasion of the sterile barrier pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinity Acetabular System Product Usage - Total Hip Replacement.
The Issue: for abrasion of the sterile barrier pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinity Acetabular Shell Product Usage: Total Hip Replacement.
The Issue: for abrasion of the sterile barrier pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crosslock DVR ePAK -Sterile
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope Titanium Single-Use Video Laryngoscope. It is a single-use video
The Issue: The firm has become aware of the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic 0-arm 02 Imaging System Catalog Number: Bl-700-02000 The O-arm
The Issue: Screws holding the detector panel in as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PINPOINT Endoscopic Fluorescence Imaging System
The Issue: It has been determined that the PINPOINT Operator's
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: software for Syngo Dynamics a Picture Archiving and Communication System
The Issue: Siemens is releasing a software update that addresses
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Large Volume Paracentesis Kit is packaged in a thermaformed tray
The Issue: Customers have reported that the pinch clamp on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Conformis iTotal Cruciate Retaining (CR) Knee Replacement System Model:...
The Issue: Incorrect femoral component distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature...
The Issue: The firm became aware that when using EtC02
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ascend¿ AQ¿ Ureteral Dilation Balloon Catheter Set The Ascend¿ AQ¿
The Issue: Cook Medical is voluntarily recalling specific lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.