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 4961–4980 of 38,428 recalls
Recalled Item: HAND PACK 297829--Procedure Kit Catalog Number: RGHN04I
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KNEE ARTHROSCOPY PACK-Procedure Kit Catalog Number: SFAR60A
The Issue: Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrathane Mac-Loc Locking Loop Multipurpose Drainage Catheter...
The Issue: Product labels state the incorrect expiration dates that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultrathane Cook-Cope Type Locking Loop Multipurpose Drainage...
The Issue: Product labels state the incorrect expiration dates that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventilator HAMILTON-C6
The Issue: Ventilator may enter sensor fail mode, ventilation may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100
The Issue: The firm received reports that some blood collection
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate
The Issue: Kit assigned an extended expiration date of 24-Jul-2025
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMT Initial Placement Dilator Set. Used to place gastrostomy devices.
The Issue: Devices were labelled with the incorrect guidewire labelling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow-B Solution
The Issue: The smaller chamber of the two chamber bag
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis
The Issue: Multiple socket-outlet power strips that shipped with automated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis
The Issue: Multiple socket-outlet power strips that shipped with automated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aeos Robotic Digital Microscope
The Issue: Possibility of the robotic arm to drop more
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sight OLO CBC Test Kit
The Issue: One Test Kit lot (TK1-10114) shows a positive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity Acute Care System (IACS) Monitoring System
The Issue: Device is not in full compliance to Type
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Guide (SC) Kit -Intended to quantitatively measure glucose in
The Issue: The reason for recall is the meters may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Darby Prophylaxis Paste with 1.23% Fluoride Ion
The Issue: Part number 040032, Lot number, 248607 was incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Sustainability Solutions
The Issue: Diagnostic electrophysiology (EP) catheters do not meet testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica HistoCore Arcadia H
The Issue: An issue with safe usage of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Ascenda Intrathecal Catheter
The Issue: Design update to the Ascenda Intrathecal Catheter Models
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.