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 9641–9660 of 38,428 recalls
Recalled Item: Centricity Universal Viewer 6.0. Used to display medical images (Including
The Issue: There is the potential that after installation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer version 5.0. Used to display
The Issue: There is the potential that after installation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit
The Issue: There is the potential for inadequate connection between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters
The Issue: There is the potential for inadequate connection between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NextAR Shoulder Surgical Technique
The Issue: A warning has been added to the Surgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent
The Issue: An error with the chromomap on version 1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE
The Issue: Upon review of its batch record, Southmedic identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic
The Issue: Confirmed an average positive bias of 40% for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GREER M. FAENI
The Issue: The product was recalled because stability evaluation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GREER DIA - KIT ANTIGEN M. FAENI
The Issue: The product was recalled because stability evaluation of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TrackX Insight Base Modular Instrument Tracker
The Issue: The device is breaking and falling off the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mighty Bliss Electric Heating Pad
The Issue: The products may have the potential to burn
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mighty Bliss Electric Heating Pad
The Issue: The products may have the potential to burn
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mighty Bliss Electric Heating Pad
The Issue: The products may have the potential to burn
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eSuction Small Cavity
The Issue: Improper device regulatory classification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infection Control (IC) Lifting Strap used with the following Cirrus
The Issue: Two customers reported four incidents in which the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1
The Issue: table stop due to a broken tabletop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Propel Mini Mometasone Furoate Sinus Implant
The Issue: Sinus Implant product label displays incorrect product information
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Busse JOINT INJECTION TRAY -Intended as a nerve block . 8561 R1
The Issue: Kits containing 3M Steri-Drape Surgical Drapes recalled by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.