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 30661–30680 of 38,428 recalls
Recalled Item: IMMULITE/IMMULITE 1000 Systems TBG
The Issue: IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component
The Issue: Some rods may not meet the appropriate traceability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TFN-ADVANCED Proximal Femoral Nailing System (TFNA)
The Issue: TFNA nails from certain lots were assembled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g
The Issue: The firm is recalling Bard MAX-CORE Disposable Core
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Genesis Malleable Penile Prosthesis
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation...
The Issue: Baxter Corporation is conducting a field action for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm
The Issue: The Continuous Radius Rod should measure 50mm in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HSG Trays/HS 5F Catheter Combo
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5
The Issue: Software anomaly regarding urine samples that require acidified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Assay Data Disk (ADD)
The Issue: Software anomaly regarding urine samples that require acidified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System
The Issue: Software anomaly allows testing of multiple assays using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Chemistry System
The Issue: Software anomaly allows testing of multiple assays using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Logicon Caries Detector Product Usage: Analyze inter-proximal tooth surfaces for
The Issue: GA Industries is recalling the Logicon Caries Detector,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liquid stable 2 part Homocysteine Reagent
The Issue: Deterioration in performance of the Liquid Stable (LS)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion AVEA ventilator
The Issue: A pressure transducer failure can develop, activating a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Winco Care Cliner Standart - Steel Casters Oncology
The Issue: Shipment of foam for chairs was received classified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology
The Issue: Shipment of foam for chairs was received classified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology
The Issue: Shipment of foam for chairs was received classified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Winco XL Convalescent Recliner - with Steel Casters Long term
The Issue: Shipment of foam for chairs was received classified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Winco Elite Care Cliner w/Swing Away Arms Standard - with
The Issue: Shipment of foam for chairs was received classified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.