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 4821–4840 of 38,428 recalls
Recalled Item: AXIOM Vertix Solitaire - The Vertix MD Trauma has been
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM MULTIX MT - Intended Radiographic X ray Table is
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM MULTIX MT - Intended Radiographic X ray Table is
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZE for Vertix Solitaire - The AXIOM Vertix Solitaire is
The Issue: Short circuit in the power supply unit (PSU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volara System. Single Patient Use (SPU) Circuit 5kit for Volara
The Issue: of the handset plug to disconnect from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volara System. Blue Ventilator Adapter Module. Intermittent positive...
The Issue: of the handset plug to disconnect from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler
The Issue: Tip holder portion of the scaler tip assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip -
The Issue: Tip holder portion of the scaler tip assembly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Tracheostomy Silicone Tube
The Issue: Smiths Medical has identified that the securement flange
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.