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 8701–8720 of 38,428 recalls
Recalled Item: SMR TT Hybrid glenoid Std - Peg S
The Issue: Shoulder glenoid fossa prosthesis was manufactured without tantalum
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCRopsis Lysis Beads
The Issue: Presence of misleading label statements on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neodent GM X 6mm Engaging Titanium Base
The Issue: Engaging titanium base contains a dimensional condition that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL
The Issue: Presence of misleading label statements on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCRopsis BCSNano (1mL)
The Issue: Presence of misleading label statements on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCRopsis Support: a) 1 mL
The Issue: Presence of misleading label statements on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCRopsis Reagent RVD-RT
The Issue: Presence of misleading label statements on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCRopsis Activator: a) 1.5mL
The Issue: Presence of misleading label statements on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PCRopsis Reagent Buccal
The Issue: Presence of misleading label statements on the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mani Trocar Kit
The Issue: A packaging defect may compromise the sterile barrier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPerfusion
The Issue: There are technical issues related to signal generation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 2D Perfusion
The Issue: There are technical issues related to signal generation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a...
The Issue: Battery leakage can cause corrosion to the metal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arjo Portable Scale Adaptor
The Issue: Some Arjo Portable Scale Adaptors have been assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agilent Resolution ctDx FIRST Sample Collection Kit
The Issue: Distributed sample collection kit with an unapproved instruction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Raystation treatment planning system for radiation therapy
The Issue: It is possible to set a non-zero collimator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITY Occipitocervical Upper Thoracic System
The Issue: Incorrect type of titanium was used which reduces
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITY Occipitocervical Upper Thoracic System
The Issue: Incorrect type of titanium was used which reduces
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITY Occipitocervical Upper Thoracic System
The Issue: Incorrect type of titanium was used which reduces
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFINITY Occipitocervical Upper Thoracic System
The Issue: Incorrect type of titanium was used which reduces
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.