FDA Medical Device Recalls
Latest medical device recalls, corrections, and removals from FDA. Stay informed about safety issues affecting medical devices.
Brand Name: Halyard Product Name: DAVINCI TRUCUSTOM BUNDLE containing TRAY FOLEY 16FR W/STATLOCK …
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
View FDA Recall →Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
View FDA Recall →American Contract System Convenience Kit, D & C PACK, Model/Catalog Number: LLPD90H
The Convenience Kits contain Medline's Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Medline Industries, L…
View FDA Recall →PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory def…
View FDA Recall →Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348…
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open…
View FDA Recall →Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be In…
View FDA Recall →NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2…
Complaints of blue-green discoloration in product
View FDA Recall →PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory def…
View FDA Recall →Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16FR(8016), 2…
An Out of Specification result (OOS) related to bacterial endotoxin testing in a single lot of catheters.
View FDA Recall →Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LI…
Kits contain a potentially contaminated component which were recalled by the manufacturer
View FDA Recall →