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 29301–29320 of 38,428 recalls
Recalled Item: XiO Radiation Treatment Planning System. Used to create treatment plans
The Issue: Incorrect Treatment Delivery Using Third Party Fixed Wedges
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConForMIS iDuo Bicompartmental Knee Replacement System iDUO G2
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConForMIS iDuo Knee Bicompartmental Knee Replacement System
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL...
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConFormis iTotal CR Knee Replacement System- ITOTAL CR - IPOLY
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConForMIS Unicondylar Knee Replacement System iUNI G2
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConFormis iDUO G2
The Issue: May contain small amounts of ethylene glycol residue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Free T3 Reagent Kit
The Issue: Beckman Coulter, Inc. is recalling Access Free T3
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Cranial Flap Tube Clamp and Crimping Device Product Usage:
The Issue: The Synthes Cranial Flap Tube Clamp and Crimping
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry XPT Chemistry Systems
The Issue: ISE module may produce discrepant, unflagged results for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD AffirM VPIII Microbial Identification Test
The Issue: BD has confirmed that a portion of tests
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRIdian¿ ViewRay¿ Radiation Therapy System
The Issue: ViewRay discovered that in the event that an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perifix Continous Epidural Anesthesia Pain Control Trays
The Issue: discoloration of the DuraPrep solution from unintended
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Cholestech LDX Multianalyte Controls
The Issue: Alere San Diego is recalling the Alere Cholestech
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Guide Wires for orthopedic procedures.
The Issue: Product labeling of these sterile guide wires (external
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
The Issue: Manufacturer of 0.9% Sodium Chloride Flush Syringes recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CD4 (SK3)
The Issue: CD4 FITC label contains an error in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Contra-Angles CA1:1L EVO 15 Catalog numbers: 1600939-001 and 1600938-001 Used
The Issue: loosening of the dental tool, which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Lab Data Manager System - Product Usage: syngo Lab
The Issue: Software Issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.