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 17681–17700 of 38,428 recalls
Recalled Item: Healing Abutment Conical Connection RP 0 3.6 x 5mm
The Issue: Packaged dental implant healing abutments were found to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 8 Fr 3 ml
The Issue: Loose silicone particulate was found to be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 6 Fr 1.5 ml
The Issue: Loose silicone particulate was found to be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SELECTSILICONE" 100% SILICONE FOLEY CATHETER 2-WAY 10 Fr 3 ml
The Issue: Loose silicone particulate was found to be present
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The ICS CHARTR EP 200
The Issue: There is a risk to the healthcare professional
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nimbus Administration Set
The Issue: for tube leakage
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories
The Issue: The device was distributed with the outer carton
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A
The Issue: The potential sporadic performance problems may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DVR Crosslock ePAK Screw Driver
The Issue: There is a potential for weak seals of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DVR Crosslock ePAK Depth Gauge
The Issue: There is a potential for weak seals of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire Trochar Tip
The Issue: There is a potential for weak seals of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.All (Model #11061630)
The Issue: The potential sporadic performance problems may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZOLL Pro-padz Liquid Gel Radiolucent
The Issue: Some of the electrodes may have been assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Top (Model #1161640)
The Issue: The potential sporadic performance problems may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM go.Now (Model #11061620)
The Issue: The potential sporadic performance problems may result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A 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: ARDVST229003A 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: ARDVST229000A 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: ARD568812910 Model:...
The Issue: that the coating of the light head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.