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 33321–33340 of 38,428 recalls
Recalled Item: Luxurian. These include all products labeled as UltraSlim
The Issue: Marketing without marketing clearance or approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultraslim. These include all products labeled as UltraSlim
The Issue: Marketing without marketing clearance or approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Photonica Light Modulator. These include all products labeled as UltraSlim
The Issue: Marketing without marketing clearance or approval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens LANTIS System
The Issue: There is a potential risk when using LANTIS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Visitec Anterior Chamber Cannula
The Issue: Contains a sharp tip needle when the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: All Philips Ingenia
The Issue: In spine clinical workflows, cross reference lines may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Horizon Medical Imaging It is a medical image and information
The Issue: The firm has identified a software issue which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The
The Issue: "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips XRE
The Issue: When using XIRIS Rio version (8.1.50.0) in conjuncture
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Triage¿ D-Dimer Test PN 98100
The Issue: Alere initiated this recall because a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kenex Radiation Shield and surgical lamps installed with GE Healthcare
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Model 8780 Ascenda Intrathecal Catheter. The implantable Medtronic...
The Issue: Medtronic has determined that an Ascenda catheter kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Triathlon Tritanium Patella Inserter
The Issue: Tritanium Patella Inserter Instrument fracture during implantation.
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaturaLyte¿ Liquid Bicarbonate Concentrate
The Issue: Foreign Object Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo software. Merge Hemo monitors
The Issue: The application may crash during the cath lab
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Robotic Arm Interactive Orthopedic System (RIO)
The Issue: Revision of the field manual
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian On-Board Imager Advanced Imaging System. The On-Board Imager device
The Issue: Varian MedicalSystems' X-ray generator Supplier (CPI) has identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1
The Issue: HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PATH(R) THREAD CUP ADAPTOR
The Issue: Difficulty removing the cup adaptor from the impaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPAX CV Pediatric Echo Reporting
The Issue: Failure to effectively install and test a hotfix
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.