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 10221–10240 of 38,428 recalls
Recalled Item: SafeControl handset (a component of the Sentida bed which moves
The Issue: When the handset is disconnected from the power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG)
The Issue: Due to a defect identified on the EPG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INTERA 3000 Hepatic Artery Infusion Pump
The Issue: Higher than expected flow rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentacam AXL
The Issue: Due to a software issue, IOL calculator printout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentacam AXL Wave . Used to image the anterior segment of the eye.
The Issue: Due to a software issue, IOL calculator printout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentacam HR . Used to image the anterior segment of the eye.
The Issue: Due to a software issue, IOL calculator printout
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T-Cell Xtend .610 US
The Issue: Due to equipment failure, affected products were stored
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PRM is intended to be used as part of
The Issue: There is potential for unanticipated software anomalies to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T-SPOT.TB .300 US
The Issue: Due to equipment failure, affected products were stored
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AIM-V Medium .200/500
The Issue: Due to equipment failure, affected products were stored
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The PRM is intended to be used as part of
The Issue: There is potential for unanticipated software anomalies to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Programmer/Recorder/Monitor (PRM) is intended to be used as part
The Issue: There is potential for unanticipated software anomalies to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ShockPulse-SE Lithotripsy Generator Model/Serial: SPL-S
The Issue: Mis-wired component-the improperly wired component can result in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZAP-X Radiosurgery System
The Issue: Software issue identified in cases of initial patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicina Oral Tip Syringe 0.5ml Code: OT005
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicina Oral Tip Syringe 2.5ml Code: OT25
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicina Reusable Oral syringe 5ml Code: OTH05
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicina Oral Tip Syringe 1ml Code: OT01
The Issue: Plunger component has been manufactured with an unapproved
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.