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 33261–33280 of 38,428 recalls
Recalled Item: Philips MR systems: Ingenia HA FLEX TRAK Trolley (for Ingenia
The Issue: Ingenia customers have experienced clamping of the foot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Temperature Ablation Catheter
The Issue: Some units of Intella Tip MiFi XP Temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Temperature Ablation Catheter
The Issue: Some units of Intella Tip MiFi XP Temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Temperature Ablation Catheter
The Issue: Some units of Intella Tip MiFi XP Temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntellaTip MiFi XP Temperature Ablation Catheter
The Issue: Some units of Intella Tip MiFi XP Temperature
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wound Drain - Label reads in part "Elutia ***Hubless Coated
The Issue: The recalling firm reported there was inadvertent omission
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MicroScan -Neg Breakpoint Combo Panel Type 34
The Issue: Siemens Healthcare Diagnostics has received complaints regarding panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack (SAK) with Concentrate for Use with PureFlow
The Issue: SAK Dialysate Concentrate contain aluminum levels which exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrasonic Transducer Kits For use with the Access Family of
The Issue: Beckman Coulter is initiating a field action because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.