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 5881–5900 of 38,428 recalls
Recalled Item: Beckman Coulter DxI 9000 Access Immunoassay Analyzer is a discrete
The Issue: The reason for the recall is the pneumatic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix Yeast ID Panel is a self-inoculating (when used
The Issue: Esculin, a substrate used in other panels and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Phoenix NMIC-306 Panel is a self-inoculating (when used with
The Issue: Products were found to have confirmed drug cross
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mariner RDX MIS Polyaxial Head
The Issue: Screw heads, of pedicle screw systems, have partial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Auto Suture" Blunt Tip Trocar
The Issue: The potential for trocar seal disengagement when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Auto Suture" Blunt Tip Trocar
The Issue: The potential for trocar seal disengagement when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Auto Suture" Blunt Tip Trocar
The Issue: The potential for trocar seal disengagement when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Auto Suture" Blunt Tip Trocar
The Issue: The potential for trocar seal disengagement when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Peri-Guard Repair Patch (new product codes): a) PG0404
The Issue: A new contraindication was added to the IFU
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Auto Suture" Blunt Tip Trocar
The Issue: The potential for trocar seal disengagement when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Auto Suture" Structural Balloon Trocar
The Issue: The potential for trocar seal disengagement when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Auto Suture" Blunt Tip Trocar
The Issue: The potential for trocar seal disengagement when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO
The Issue: A new contraindication was added to the IFU
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO
The Issue: A new contraindication was added to the IFU
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareEvent Event Management System
The Issue: It was found that the Care Assist mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Patient Information Center iX (PIC iX)
The Issue: It was found that the Care Assist mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404
The Issue: A new contraindication was added to the IFU
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis VIP ambulatory Infusion Pumps
The Issue: The CADD Solis VIP Ambulatory Infusion Pump is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis Ambulatory Infusion Pumps
The Issue: CADD-Solis Ambulatory Infusion Pumps, with software versions before
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CADD-Solis VIP ambulatory Infusion Pumps
The Issue: The CADD Solis VIP Ambulatory Infusion Pump is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.