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The FDA warns that Johnson & Johnson subsidiary Animas Corp.'s recalled insulin pumps "may cause serious adverse health consequences, including death."

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The FDA put its highest-risk category on Johnson & Johnson (NYSE:JNJ) subsidiary Animas Corp.'s insulin pump recall over concerns that the devices may cause patient harm or even death.

Certain pumps were recalled over concerns that a "component" issue could trigger a false alarm or a sudden warning requiring that the patient rewind, load and prime the device.

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