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 10641–10660 of 38,428 recalls
Recalled Item: LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
The Issue: It was reported that a JOURNEY II BCS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump Models: 3500
The Issue: Multiple issues with the potential for interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medfusion Syringe Pump Model: Model 4000-0100-50
The Issue: Multiple issues with the potential for interruption of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Replacement back up batteries distributed on or after April 1
The Issue: Insufficient battery backup power resulting in premature shutdown
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Back up batteries in Ventilators labeled as the following: a.
The Issue: Insufficient battery backup power resulting in premature shutdown
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: progenamatrix Human Keratin Matrix
The Issue: Inner pouch seal may be inadequate resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test
The Issue: FDA review concluded that the test is insufficiently
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Turbett Surgical Container
The Issue: Devices were subject to unapproved rework processes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare HVAD Pump Implant Kit
The Issue: The pump may have a welding defect that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200 ToRC IgM Reagent Pack
The Issue: Performance concerns for the CMV IgM analyte. Analyte
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe
The Issue: Patient chart label contains incorrect Part Number and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1300 Analyzer - automated
The Issue: Lots incompatible with Test Definition (TDef) Version 1.4,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1
The Issue: A Size 2 trial baseplate was assembled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica IM 1600 Analyzer - automated
The Issue: Lots incompatible with Test Definition (TDef) Version 1.4,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber
The Issue: Verification of installation not documented or may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sensis
The Issue: Siemens has become aware of three potential software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe
The Issue: Product labeled incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as
The Issue: Verification of installation not documented or may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Voalte Nurse Call System provides a comprehensive communication and information
The Issue: Firm discovered a firmware memory leak with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NaviCare Nurse Call System provides a comprehensive communication and...
The Issue: Firm discovered a firmware memory leak with a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.