Albograft Surgical Graft Recall Issued After Bleeding Incident
Leaking vascular grafts used to repair damaged arteries were recalled after blood was seen leaking through them after implantation.
Tag Archives: Medical Device Recall
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GlideScope Video Laryngoscope Recall Issued Over Defective Blades
the FDA warns that recalled GlideScope Video Laryngoscope blades could break in patients' mouths, putting them at risk of severe injury or death.
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AFX Introducer Recall Issued Due to Risk of Dilator Breaking During Use
The FDA has announced a class I recall for the AFX Introducer System by Endologix, Inc after reports of dilators that broke during medical procedures.
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EZ Breathe Atomizer Recall Issued Due to Choking Hazard
Nearly a quarter of a million EZ Breathe Atomizers have been recalled, due to the risk that a small washer in the device may become dislodged during use and potentially…
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SealFlex Infant Medical Mask Recall Issued Due to Labeling Error
Federal health regulators have determined that SealFlex ribbed infant masks shipped to hospitals in five states could pose a serious risk for young children, because they were mislabeled as infant…
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Newport HT70 Ventilator Battery Recall Issued Due to Risk of Failure
Reports of power loss and false readouts have resulted in an international recall of ventilator Power Pac batteries due to the potential health risks that these problems could cause for…
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BCI Remote Cable Recall Issued Due to Alarm Failure
Several lots of BCI alarm cables needed to activate life-saving alarms in hospital settings could fail, potentially posing a risk of severe injury or death for patients, federal health officials…
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Guardian II Hemostasis Valve Recall Issued For Air Embolism Risk
Federal health officials have ordered hospitals to remove several lots of Guardian II hemostasis valves from their inventory because they could cause patients to suffer a deadly air embolism.
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Stryker Receives FDA Warning Letter Over Manufacturing Process
Following an inspection at one of its production facilities, the FDA issued a warning letter to Stryker Corporation over quality issues involving its medical device manufacturing practices.
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Lumenis VersaCut Recall: Mislabeling Could Lead to Air Embolism
Recent problems with the warnings and instructions provided on a medical device used to remove tissue during surgery, which could cause an air embolism if the tubing is hooked up…