Product Recall
Alcon recalls one lot of Systane single-use eye drops due to fungal contamination
Alcon Laboratories announced the voluntary recall of one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, following a consumer complaint that led to the discovery of fungal contamination in the drops.
Premarket research not conducted for many CV devices subject to class I recall
Many recently recalled cardiovascular devices did not undergo premarket testing prior to FDA approval, and postmarket studies of the devices were slow and infrequent, researchers reported.
Top in endocrinology: Price cuts for Medicare Part D drugs; tirzepatide vs. GLP-1s
Beginning in 2026, prices for 10 drugs will be reduced for Medicare Part D recipients, according to a CMS press release.
Tandem updates recall of mobile app causing rapid battery depletion of insulin pumps
Tandem Diabetes Care emailed notices to users of version 2.7.1 of the Apple iOS t:connect mobile app warning of possible rapid battery depletion of their insulin pump, according to an FDA press release.
Recall of LVAD implant kit designated class I; two deaths reported
Abbott/Thoratec Corp. announced the recall of its left ventricular assist device implant kit due to complaints of blood leakage or air entering the seal interface between the LVAD inflow cannula and the apical cuff.
Fresenius Kabi recalls Ivenix Infusion System software over ‘anomalies’
Large volume infusion pump software related to the Ivenix Infusion System has been recalled by its manufacturer due to multiple potentially dangerous issues, according to a press release from the FDA.
FDA designates recall of LVAD communication system as class I
Abbott announced it is recalling its left ventricular assist device communication system due to risk for unexpected pump stop or start.
ResMed CPAP masks subject to Class I recall over magnetic interference issue
Six reported injuries related to magnets on the headgear of CPAP machines by ResMed Ltd. have resulted in a recall the FDA labels as class I, the most serious kind, according to an an FDA alert.
FDA designates recall of heart-lung machine emergency drive as class I
Getinge announced it is recalling its heart-lung machine emergency drive due to an issue that could prevent the ability of the emergency drive to be cranked.
Amazon removes eye drops from website after FDA warning
After receiving a warning letter from the FDA, the online retailer Amazon removed seven unregulated eye drop products from its website.