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 36341–36360 of 38,428 recalls
Recalled Item: Bacterin Elutia
The Issue: A portion of a silicone wound drain was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica
The Issue: Diagnostica Stago has confirmed that sometimes the delta
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Isoline Implantable Defibrillation Lead
The Issue: Isoline defibrillation leads distributed may have internal insulation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The...
The Issue: Philips HeartStart XL+ Defibrillator/Monitor may become locked out
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELECTROLASE(R) HYFRECATOR(R) ELECTRODES - BLUNT
The Issue: Some devices had broken through the seal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELECTROLASE HYFRECATOR(R) ELECTRODES - SHARP
The Issue: Some devices had broken through the seal of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Varian Eclipse Treatment Planning System for Radiotherapy
The Issue: The calculation of dose dynamic plans containing different
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prism Medical C-Series Carry Bar
The Issue: The firm replaced the recalled carry bar with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged
The Issue: This product is not cleared for marketing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series
The Issue: Covidien is correcting labeling to clarify the operational
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN
The Issue: Covidien is correcting labeling to clarify the operational
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proplege Coronary Sinus Catheter model PR9
The Issue: Edwards Lifesciences is recalling certain Proplege Coronary Sinus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is
The Issue: This product is not cleared for marketing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KY TINGLING JELLY Personal Lubricant. The product is packaged into
The Issue: This product is not cleared for marketing in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HLD System
The Issue: The temperature sensor/control system in the HLD Systems
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: User Manual addendum
The Issue: Change to User Manual to remove one indication
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stelkast Cross-over Acetabular Shell and Liner Hip System
The Issue: Firm was made aware of incidents relating to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Howmedica Osteonics Corp. Stryker Orthopaedics Specialty Triathlon Left and...
The Issue: The standard Triathlon Femoral Stylus does not fit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D3000I Advantage Drive System
The Issue: The Membrane Switch Panel (referred to as "front
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D3000 Advantage Drive System
The Issue: The Membrane Switch Panel (referred to as "front
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.