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 29201–29220 of 38,428 recalls
Recalled Item: Envoy 500 system includes the following product numbers and
The Issue: ELITech clinical Systems reagents based on Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Eon 300 system includes the following product numbers and
The Issue: ELITech clinical Systems reagents based on Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sentinel MULTIGENT Ammonia Ultra Reagent
The Issue: Results for ammonia are below the linear range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra¿ Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical
The Issue: Integra received an Urgent Drug Recall Notice from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TheraSphere(R) YTTRIUM-90 CLASS MICROSPHERE INJECTION TheraSphere¿ is...
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Valeant Pharmaceuticals North America
The Issue: The Serial I.D. Label and some information in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i
The Issue: Inadequate biocompatibility testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i
The Issue: Inadequate biocompatibility testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i
The Issue: Inadequate biocompatibility testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOMET 3i
The Issue: Inadequate biocompatibility testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile.
The Issue: Stryker Orthopaedics has received two customer complaints regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Pak 9319-27. Single-use medical devices and accessories designed by
The Issue: The recalled lot of custom paks are labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Digital Lightbox
The Issue: Potentially incorrectly displayed objects when actively deselecting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Screw Inserter
The Issue: Certain lots of the Screw Inserter may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 4FR Single Lumen Pressure Injectable PICC
The Issue: Labeling inaccuracy in the Instructions for Use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DuraDiagnost stationary X-ray system
The Issue: Buttons or keys on the monitor allow the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Boston Scientific SQ-RX Model 1010 subcutaneous pulse generator
The Issue: Devices shipped to US in dual-channel rather than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disposable Paper Filter for Sterilization Containers Paper
The Issue: Stryker has become aware that the inhomogeneity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CC cartridges for IRMA TRUPOINT Blood Gas Analyzer
The Issue: May report values outside the published performance specifications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BG cartridges for IRMA TRUPOINT Blood Gas Analyzer
The Issue: May report values outside the published performance specifications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.