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 581–600 of 38,428 recalls
Recalled Item: BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm
The Issue: Labeling discrepancy; Ureteral stent actual size may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard InLay Optima Size: 6 Fr. x 14 cm
The Issue: Labeling discrepancy; Ureteral stent actual size may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm
The Issue: Labeling discrepancy; Ureteral stent actual size may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safe-T-Centesis 6 Fr Catheter Drainage Tray
The Issue: Acute drainage catheters, indicated for use in removing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD InLay Optima Ureteral Stent Kit Size: 8 Fr. x 26 cm
The Issue: Labeling discrepancy; Ureteral stent actual size may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diasol Product Name: 100425-10-DEX100
The Issue: Safety and efficacy of dialysis acid concentrate cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diasol Product Name: 100225-10-DEX100
The Issue: Safety and efficacy of dialysis acid concentrate cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diasol Product Name: 100220-10-DEX100
The Issue: Safety and efficacy of dialysis acid concentrate cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diasol Product Name: 100325-10-DEX100
The Issue: Safety and efficacy of dialysis acid concentrate cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diasol Product Name: 100125-10-DEX100
The Issue: Safety and efficacy of dialysis acid concentrate cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diasol Product Name: 100230-10-DEX100
The Issue: Safety and efficacy of dialysis acid concentrate cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemochron Activated Clotting Time Low-Range Test Cuvette
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10.
The Issue: Product testing did not meet expected stability criteria
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue. Intra-Aortic Balloon Pump system.
The Issue: The IFU addendum revises the Preventative Maintenance schedule
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
The Issue: The IFU addendum revises the Preventative Maintenance schedule
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SQ40S Blood Transfusion Filter
The Issue: Due to products being released for distribution prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Parasite Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adrenal Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neurotransmitters Plus
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pollen Allergy Test
The Issue: Distribution without premarket approval/clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.