Topic:
Recalls
Latest Headlines
Latest Headlines
Endologix endures FDA deadly warning over recall
Endologix recalled its AFX Introducer System back in May, and now the FDA has assigned its most serious warning to the catheter-insertion device, saying it could cause serious injury or death.
Cook's Zilver stent recall could be a costly one
Cook Medical's ongoing recall of its Zilver PTX stent could be a costly one.
FDA sticks 'deadly' tag on Cook's stent recall
The FDA has affixed its most serious warning to Cook Medical's recall of the Zilver PTX stent, warning that problems with the device's delivery catheter could lead to thrombosis, amputation or death.
FDA slaps 'deadly' label on Abbott's glucose meter recall
In April, Abbott Laboratories announced it was yanking the FreeStyle InsuLinx blood glucose meters off the U.S. market, and now the FDA has assigned its most-serious Class I label to the effort, warning that the devices' malfunction could lead to serious injury or death.
Medtronic lops off 230 spinal jobs, endures FDA blemish
Medtronic is following through on its long-held plans to slash jobs in its spinal business, cutting 230 positions as revenues falter. Meanwhile, the FDA slapped its most serious recall label over a potentially deadly flaw with the device giant's deep-brain stimulators.
FDA slaps Class I on Covidien's ventilator battery recall
Last month, Covidien launched a recall of battery packs used with its Newport HT70 ventilators, and now the FDA has assigned its most serious designation to the problem, warning that the malfunctioning batteries could lead to injury or death.
Cook recalls Zilver PTX over delivery problem
Cook Medical has launched a global recall for its banner Zilver PTX stent, warning that a small number of the devices broke from their delivery catheters during implantation, a problem that has already led to one death.
J&J's glucose meter recall gets FDA's most serious tag
Last month, Johnson & Johnson voluntarily recalled three models of its market-leading LifeScan glucose meters, and now the FDA has slapped a Class I label on the stateside effort, warning that use of the device could lead to serious injury or death.
CareFusion endures another Class I pump recall
CareFusion was plagued by regulatory problems all last summer, and now the company is reporting an issue with another model of its Alaris infusion pumps, earning the FDA's most-serious warning.
Covidien recalls ventilator batteries over failure risk
Covidien is recalling certain battery packs used with its Newport HT70 ventilators, warning that they may fail to charge or revert to emergency backups, putting patients at risk for adverse events.
