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 23941–23960 of 38,428 recalls
Recalled Item: ECT Internal Fracture Fixation Quick-Connect Drill 2.5 mm Diameter 11 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 2.5 mm Diameter (.098 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 Drill 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.
Recalled Item: Straight Shank Drill Bit 4.0 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: ECT Internal Fracture Fixation Drill 4.5 mm Diameter (.177 Inch)
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 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: Zimmer Periarticular Locking Plate System Locking Screw Tap Standard...
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 3.2 mm Diameter (.126 Inch)
The Issue: Various trauma and extremity instruments (drill bits and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 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 1.5 mm Diameter (.059 Inch)
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 1.5 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: MULTIGENT Creatinine (Enzymatic)
The Issue: Reagent 1 component may result in Quality Control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROMETRA II Programmable Infusion Pump
The Issue: Flowonix Medical received a report of a patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Olympic Pasteurmatic 3000 and Olympic Pasteurmatic 3500 are intended
The Issue: Olympic Pasteurmatic 3000/3500 Systems are recalled because they
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coulter PrepPlus
The Issue: When samples are prepared using the PrepPlus or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coulter PrepPlus 2
The Issue: When samples are prepared using the PrepPlus or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIASTAT(R) ANA (anti-Nuclear antibody) EURO DIAGNOSTICA
The Issue: FANA200 kit lot TS 3577 was re-worked due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exactech 1.5" Novation Calcar Planer Guide Tip To assist the
The Issue: The firm determined that the labeling (surgical technique)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Zurpaz(TM) MEDIUM CURL
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific Zurpaz(TM) MEDIUM CURL
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.