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 3021–3040 of 38,428 recalls
Recalled Item: AnchorFast Guard Select
The Issue: Hollister received reports of decreased skin barrier wear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AnchorFast Guard
The Issue: Hollister received reports of decreased skin barrier wear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lev5
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CyberKnife Treatment Delivery System
The Issue: Snap rings may become partially or completed detached
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE ARTERIAL LINE PACK
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CENTURION Infusion Catheter
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VDR4 Phasitron Breathing Circuit Models that contain the venturi component:
The Issue: Due to internal venturi component getting transiently stuck
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial use
The Issue: Due to faulty circuit board in speed control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial use
The Issue: Due to faulty circuit board in speed control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROLENE Polypropylene Suture
The Issue: Sutures may have an open seal on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETHIBOND EXCEL Polyester Suture
The Issue: Sutures may have an open seal on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PERMA-HAND Silk Suture
The Issue: Sutures may have an open seal on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN:
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN:
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN:
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN:...
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN:...
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN:...
The Issue: Reported Outer sheath distal black tip detaching from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.