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 22901–22920 of 38,428 recalls
Recalled Item: Medline Prefilled 350 ml Sterile¿¿¿¿ ¿¿¿¿ ¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Unit Dose 5 ml Normal Saline (0.9%)¿¿¿¿ ¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline 300-350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex Unit Dose 15 ml Normal Saline ¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Prefilled 550 ml Sterile¿¿ ¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intermed 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex 550 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex 500 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Portex 1000 ml Sterile Water USP Pour Bottle¿¿¿¿ ¿¿¿
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Irrisept OR
The Issue: Lack of sterility assurance: leaking containers which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Positioning System with KRC2 controller using software versions 2.3.1
The Issue: Communications between the Patient Positioning System and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELAN 4 Blade: ELAN 4 1-RING PIN CUTTER D1.0 ELAN
The Issue: ELAN 4 burr/blade accessories were marketed without 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELAN 4 Burr: ELAN 4 1-RING ROSEN BURR+ D0.6 ELAN
The Issue: ELAN 4 burr/blade accessories were marketed without 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELAN 4 Drill: ELAN 4 1-RING TWIST DRILL D1.5 ELAN
The Issue: ELAN 4 burr/blade accessories were marketed without 510(k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respire Pink H/S Oral Sleep Apnea Device
The Issue: for device breakage during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respire Pink H/S Oral Sleep Apnea Device
The Issue: for device breakage during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respire Pink Series EF+ Oral Sleep Apnea Device.
The Issue: for device breakage during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Respire Pink+ Hard/Soft Oral Sleep Apnea Device
The Issue: for device breakage during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.