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 27101–27120 of 38,428 recalls
Recalled Item: AVEA Standard ventilator-
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVEA Comprehensive ventilator
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVEA Comprehensive ventilator-
The Issue: CareFusion has identified a potential risk associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 5195GM
The Issue: Cadillac First Aid Kit is recalled because it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: enGen Laboratory Automation System
The Issue: If the user selects the Comment or Interpretation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Item # 4042-CPR Rescue Kit
The Issue: First aid kits or rescue kits are recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexichamber Anti-Static Valved Collapsible Holding Chamber
The Issue: Product had torn/loose seal around the mouthpiece
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Innocor Cardiopulmonary Exercise and Lung Function Testing System...
The Issue: The purpose of the recall is to replace
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Saw Sagittal Catalog Number: ES 300
The Issue: Medtronic Powered Surgical Solutions testing of the Sagittal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit &
The Issue: It was discovered during post-quarantine packaging on 2/16/2016
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19
The Issue: A patient weight can be populated incorrectly under
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COSEAL Surgical Sealant Kit
The Issue: for incomplete dissolution of the polyethylene glycol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COSEAL Surgical Sealant Kit
The Issue: for incomplete dissolution of the polyethylene glycol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COSEAL Surgical Sealant Kit
The Issue: for incomplete dissolution of the polyethylene glycol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iGUIDE System
The Issue: If by mistake the initial pre-treatment imaging was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medicine Cup
The Issue: There is 5 mL printed next to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or
The Issue: Premature bucket failures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norian Drillable Inject 10 CC-Sterile
The Issue: DePuy Synthes is initiating a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Persona Trabecular Metal Tibia
The Issue: Zimmer Inc. is initiating a recall of specific
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Norian Drillable Inject 3 CC-Sterile
The Issue: DePuy Synthes is initiating a voluntary medical device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.