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 17701–17720 of 38,428 recalls
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model:...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model:...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model:...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model:...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model:...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model:...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT BNP Calibrators Ptoduct Usage: The ARCHITECT BNP Calibrators are
The Issue: Presence of a time dependent, stability drift in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT BNP Controls Ptoduct Usage: The ARCHITECT BNP Controls are
The Issue: Presence of a time dependent, stability drift in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan: 1) EZ-ENDO 6.0 mm
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan: 1) CF 6.0 mm
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan: 1) HVT 6.0 mm
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheridan/CF Novaplus 7.0 mm
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan LTS
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sheridan/HVT: 1) Novaplus 7.0 mm
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm
The Issue: Multiple complaints were received for balloons bursting below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm
The Issue: Multiple complaints were received for balloons bursting below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hudson RCI Sheridan: 1) Preformed 6.0 mm
The Issue: This voluntary recall is due to reported complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advance Enforcer 35 Focal Force PTA Balloon Catheter 6mm x 4cm
The Issue: Multiple complaints were received for balloons bursting below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.