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 3461–3480 of 38,428 recalls
Recalled Item: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190. Model Number: GIF-1TH190
The Issue: High-level disinfection ("HLD") with Acecide-C disinfectant in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BACTEC 9240 System Version or Model: 445475 Catalog Number: 445475
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD COR MX Instrument Version or Model: 443989 Catalog Number: 443989
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD EpiCenter Data Management System Version or Model: 440887 Catalog
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD COR PX Instrument Version or Model: 443988 Catalog Number: 443988
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BACTEC FX40 Instrument Version or Model: 442296 Catalog Number: 442296
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BACTEC 9120 System Version or Model: 445570 Catalog Number: 445570
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix M50 Automated Microbiology System Version or Model: 443624
The Issue: BD confirmed that product service credentials used by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cook Medical HEMO-7-EU Hemospray Endoscopic Hemostat
The Issue: Specific lots of product have been manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used
The Issue: Recalled lot does not meet specification and has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm
The Issue: Due to manufacturing defects observed on Locking Caps
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm
The Issue: Due to manufacturing defects observed on Locking Caps
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY
The Issue: Femoral implant porous size 5 right primary and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIORAPTOR Suture Anchors. Tendon/ligament
The Issue: Sterile barrier breach due to inadequate packaging design
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Galaxy System (GAL-001). Intended to provide bronchoscopic visualization of and
The Issue: Bronchoscopic visualization system power supplies have defective semiconductor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS Artificial Urinary Sphincter Control Pump
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS Artificial Urinary Sphincter Pressure Regulating Balloon 61-70 cm H2O
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical PORTEX Tracheal Tube Exchange Guide
The Issue: Smiths Medical has identified a potential for ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Architect AIR
The Issue: Gradient coils for certain MR systems (see affected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical PORTEX Tracheal Tube Exchange Guide
The Issue: Smiths Medical has identified a potential for ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.