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 2121–2140 of 38,428 recalls
Recalled Item: Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate
The Issue: Cook Medical identified that catheters supplied in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contamac
The Issue: Contact lens insertion solution may lack sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula
The Issue: due to complaints received for 3mm to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog
The Issue: due to complaints received for 3mm to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog
The Issue: due to complaints received for 3mm to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog
The Issue: due to complaints received for 3mm to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number:
The Issue: due to complaints received for 3mm to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula
The Issue: due to complaints received for 3mm to 4mm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ami HTX.
The Issue: The X-ray safety and manufacturing date labels affixed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lago X
The Issue: The X-ray safety and manufacturing date labels affixed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCD Comfort Knee Length Small
The Issue: Incorrect software logic may cause frequent E1 errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kendall SCD Blended Comfort Sleeves Knee Length Small - For
The Issue: Incorrect software logic may cause frequent E1 errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kendall SCD Comfort Sleeves Knee Length Small
The Issue: Incorrect software logic may cause frequent E1 errors
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allon 2001. Part Number: 200-00263
The Issue: An investigation into a report of the patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Evolution Upgrade 3.0T
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia 3.0T CX
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia 1.5T CX
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: MR 7700
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia Elition X
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Ingenia 3.0T
The Issue: for alignment errors in the cross reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.