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 23881–23900 of 38,428 recalls
Recalled Item: SHIMADZU FDR Visionary Catalog Number: FDR Visionary Suite Stationary x-ray
The Issue: Cracks may occur over time on the tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM
The Issue: The device collar size was incorrectly labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SHIMADZU Ceiling Type X-ray Tube Support CH-200/CH-200M Catalog Number:...
The Issue: Cracks may occur over time on the tube
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage:
The Issue: Underestimates the lead concentration of venous blood samples
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product
The Issue: Underestimates the lead concentration of venous blood samples
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Ranger(TM) Pressure Infusor
The Issue: It was discovered that one Ranger Pressure lnfusor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number:
The Issue: 55 kits were distributed after their expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SST TWIST DRILL
The Issue: One lot was found to contain both the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TUMARK Q
The Issue: There is a potential risk of puncture to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM)
The Issue: Listeria Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo.plaza
The Issue: Siemens is releasing a non-medical software application LTA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 10 cm Length
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill Bit Jacobs Chuck 2.0 mm Diameter 85 mm Length
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Long Drill 1/4 inch (6.4 mm) Diameter 8 inch (20.3 cm) Length
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECT Internal Fracture Fixation Drill Bits 2.0 mm Diameter (.079 Inch)
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECT Internal Fracture Fixation Quick-Connect Drill 2.7 mm Diameter 10 cm Length
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Periarticular Locking Plate System Drill Standard 2.0 mm Diameter
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill Bit Quick-Connect 1.1 mm Diameter 60 mm Length
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECT Internal Fracture Fixation Drill Bits 2.7 mm Diameter (.106 Inch)
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.