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 36281–36300 of 38,428 recalls
Recalled Item: Plum A+ Hyperbaric Infusion Pump. List Number 11005. The Plum
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+3 Infusion Pump. List Number 12618. The Plum A+
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Infusion Pump. List Number 11971. The Plum A+
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Infusion Pump with Hospira MedNet Software. List Number
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+3 Infusion Pump with Hospira MedNet Software. List Number
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+3 Infusion Pump. List Number 12391. The Plum A+
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Infusion Pump. List Number 11973. The Plum A+
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+3 Infusion Pump System. List Number 12348. The Plum
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum A+ Infusion Pump with Hospira MedNet Software. List Number
The Issue: The fluid shield diaphragm for the Plum A+
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heritage Labs Path Study Extra Supplies Kit
The Issue: The product has a Lithium Heparin contaminant which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smiths Medical
The Issue: In rare instances, the BCI¿ Remote Alarm Cables
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux VITEK 2 AST-ST01 Streptococcus Susceptibility Card
The Issue: The product package did not contain the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled
The Issue: Observed instability of the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbiq Two Channel Infuser
The Issue: Hospira has received reports of Malfunction S205 Backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbiq One Channel Infuser
The Issue: Hospira has received reports of Malfunction S205 Backup
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cordis EMPIRA RX PTCA Dilatation Catheter Catalog # 85R30300S For
The Issue: Dilatation catheters could exhibit radial versus axial tears
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SpineNet Anterior Cervical Cage
The Issue: The recall decision has been made because because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vitrea Enterprise Suite
The Issue: Vital Images has found a potential error in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Specialist 2 IM Rod
The Issue: for the IM rod to break, leaving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual
The Issue: The Straight Ringloc Button Latch Inserter Handle may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.