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 31401–31420 of 38,428 recalls
Recalled Item: Sensei X Robotic Catheter System
The Issue: The Set Up Joint subassembly of the Sensei
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers:
The Issue: There is the potential for a breach in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle
The Issue: There is the potential for a breach in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ev3
The Issue: Two production lots of the Protege Rx Tapered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented...
The Issue: The affected lot was supplied by contract manufacturer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Self-Righting Luer Lock Tip Cap
The Issue: Baxter Corporation initiated a recall of two lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The
The Issue: Zimmer received a single complaint wherein a Trilogy®
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical
The Issue: The recalled devices labeling and instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kinetic
The Issue: The recalled devices labeling and instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rotoprone Therapy System. The Rotoprone Therapy System is an advanced
The Issue: The recalled devices labeling and instructions for use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2
The Issue: If the SpO2 or RRa value is violating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ferno Model 35X PROFlexx Stretchers
The Issue: The wheel castor assemblies may be loosening on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM Force
The Issue: Artifacts are found in acquired imaging on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: POWEREASE Instruments Set Screw Breakoff Instrument
The Issue: The retaining tabs component of the Set Screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q
The Issue: Suboptimal routing of the cable may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IR remote control JUPITER U
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (R)Cable remote control JUPITER
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cable remote control JUPITER / TS7500
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cable remote control JUPITER U
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cable remote control JUX Material
The Issue: Complaints have been reported of unintended movement occurring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.