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 31841–31860 of 38,428 recalls
Recalled Item: 8MM
The Issue: Deviations in reprocessing steps from those stated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8MM
The Issue: Deviations in reprocessing steps from those stated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8MM
The Issue: Deviations in reprocessing steps from those stated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8MM PERMANENT CAUTERY SPATULA
The Issue: Deviations in reprocessing steps from those stated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8MM
The Issue: Deviations in reprocessing steps from those stated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8MM
The Issue: Deviations in reprocessing steps from those stated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8MM
The Issue: Deviations in reprocessing steps from those stated in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8MM Recalled by Intuitive Surgical, Inc. Due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Product Usage: MOSAIQ is an oncology information system used
The Issue: A problem can exist in MOSAIQ resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 The primary...
The Issue: Packaging non-conformance related to the integrity of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator
The Issue: The firm has found that the Component- Dianz
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda
The Issue: Medtronic initiated an Urgent Medical Device Recall for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable
The Issue: Software upgrade to correct potential safety issue related
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHEK Connect Diabetes Management App
The Issue: Roche Diabetes Care has become aware of an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESTREAM DIRECTVIEW CR Software Generates digital mammographic images that can
The Issue: Reduced mammographic image quality when attempting to print
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITI VISION SYSTEM ULTRASOUND FMS. Single-use fluid management system....
The Issue: Alcon is conducting a medical device recall due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Crea A and B membranes
The Issue: Negative drift on QC during in-use lifetime of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel TB Potassium Permanganate (.5% Aqueous) 40192
The Issue: The product may appear cloudy or discolored and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Esprit V1000 Ventilator and Esprit/V200 Conversion Ventilator The Esprit V1000
The Issue: If the power supply fan mounting screws are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM
The Issue: The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.