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 5981–6000 of 38,428 recalls
Recalled Item: Situate Laparotomy Sponge
The Issue: Packs including 5 laparotomy sponges may contain incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 20 Fr Safety PEG Push w/ENFit Kit (Box 2)-Indicated
The Issue: Inability to advance the guidewire through the feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 20Fr Push Standard PEG Kit w/ENFit (Box 2)-Indicated for
The Issue: Inability to advance the guidewire through the feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 20Fr Push Safety PEG Kit w/ENFit (Box 2)-Indicated for
The Issue: Inability to advance the guidewire through the feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 20Fr Push Standard PEG Kit (Box 2)-Indicated for enteral
The Issue: Inability to advance the guidewire through the feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EndoVive 20Fr Push Safety PEG Kit (Box 2)-Indicated for enteral
The Issue: Inability to advance the guidewire through the feeding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HALYARD SURGICAL HOOD
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiovascular Procedure Kits that include High Crack Check Valve PN
The Issue: Pressure relief valve included in certain lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Tube Securement Device
The Issue: Manufacturing nonconformities are in some lots of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Obsidio Conformable Embolic
The Issue: An investigation determined that delivery of the Obsidio
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific iSLEEVE EXPANDABLE Introducer Set
The Issue: Boston Scientific is conducting a removal of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate 3 Left Ventricular Assist System (LVAS): 1. HeartMate 3
The Issue: Observed outflow graft deformation known as Extrinsic Outflow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartMate II Left Ventricular Assist System (LVAS): 1. HeartMate II
The Issue: Observed outflow graft deformation known as Extrinsic Outflow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Convatec EsteemBody Soft Convex
The Issue: Convatec Inc is conducting a Voluntary Medical Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Electrosurgical Knife Product Name: Olympus Single
The Issue: A deterioration of the cutting knife, including overheating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Single Use Electrosurgical Knife KD-645 Product Name: Olympus
The Issue: A deterioration of the cutting knife, including overheating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Origio Sperm Wash Medium Pack of Five 60ml bottles -
The Issue: Low concentration of sodium pyruvate in the wash
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Origio Sperm Wash Medium Pack of Ten 10ml bottles -
The Issue: Low concentration of sodium pyruvate in the wash
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Origio Sperm Wash Medium Pack of Five 60ml bottles -
The Issue: Low concentration of sodium pyruvate in the wash
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medivance Neonatal ArcticGel Pads
The Issue: Neonatal pads are experiencing reduced water flow, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.