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 3141–3160 of 38,428 recalls
Recalled Item: CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model
The Issue: for certain SKUs and lot numbers were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Fluid Delivery Set with Drip Chamber: 1) MTO
The Issue: Fluid Delivery Sets were incorrectly assembled with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Fluid Delivery Set with Drip Chamber: 1) FDS
The Issue: Fluid Delivery Sets were incorrectly assembled with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LithoCrushV Single Use Mechanical Lithotriptor V. Model Number:...
The Issue: for distal tip tearing of the Mechanical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1)
The Issue: Complaints have been received regarding post-operative implant collapse
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wolf-Pak Product Name: Premium Dressing Change Kit with
The Issue: for hole in package compromising sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMed Products Product Name: Dressing Change Kit with
The Issue: for hole in package compromising sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wolf-Pak Product Name: Dressing Change Kit with Cloth
The Issue: for hole in package compromising sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wolf-Pak Product Name: Dressing Change Kit with Transparent
The Issue: for hole in package compromising sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tacy Medical
The Issue: for hole in package compromising sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panther Fusion GBS Assay Kit containing Panther Fusion
The Issue: weak pouch seal on Panther Fusion GBS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTiva
The Issue: Vagus nerve stimulator generators may stop delivering stimulation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SenTiva
The Issue: Vagus nerve stimulator generators may stop delivering stimulation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DLP Pediatric One-Piece Arterial Cannulae
The Issue: Incorrect labeling for seven manufactured lots of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EOPA Arterial Cannula
The Issue: Incorrect labeling for seven manufactured lots of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Select Series Angled Tip Arterial Cannula
The Issue: Incorrect labeling for seven manufactured lots of certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT DR Pacemaker
The Issue: A subset of devices from the ACCOLADE Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella RP Flex with SmartAssist
The Issue: Optical Sensors have been damaged due to physical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESSENTIO DR Pacemaker
The Issue: A subset of devices from the ACCOLADE Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VALITUDE CRT-P
The Issue: A subset of devices from the ACCOLADE Family
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.