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 241–260 of 38,428 recalls
Recalled Item: Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON...
The Issue: These lots of reprocessed catheters may contain small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology...
The Issue: These lots of reprocessed catheters may contain small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters:...
The Issue: These lots of reprocessed catheters may contain small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters:...
The Issue: These lots of reprocessed catheters may contain small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE
The Issue: These lots of reprocessed catheters may contain small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LSL Healthcare
The Issue: BD ChloraPrep Triple Swabsticks, a component within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Information Center iX
The Issue: A recent software (SW) patch modifies Mobile Event
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Clearest Strep-A Cassette Test. Test to determine the presence of
The Issue: Product not cleared by the FDA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bisaf Strep A Self-Test. Test for detection of
The Issue: Product not cleared by the FDA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wondfo Streptococcal A At-Home Self-Test. At-home test for group A
The Issue: Product not cleared by the FDA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification...
The Issue: To remove the software applications from certain CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm
The Issue: Increased reports of stent deployment and expansion issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm
The Issue: Increased reports of stent deployment and expansion issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm
The Issue: Increased reports of stent deployment and expansion issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT...
The Issue: To remove the software applications from certain CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm
The Issue: Increased reports of stent deployment and expansion issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE
The Issue: A specific lot of screws is incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT...
The Issue: To remove the software applications from certain CT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm
The Issue: Increased reports of stent deployment and expansion issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm
The Issue: Increased reports of stent deployment and expansion issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.