The FDA is alerting patients and healthcare providers to inspect Amneal and Impax epinephrine auto-injectors. Some products were found to not have the yellow “stop collar” in place, which could cause the injector to release a double dose.
The FDA is alerting patients and healthcare providers that certain EpiPen auto injectors may have a delayed response or may fail to inject.
FDA warns healthcare providers about off-label use of Stryker Wingspan stent system.
FDA warns consumers about unauthorized sale of previously owned test strips:
FDA safety communication urges caution when using robotically-assisted surgical devices in
certain women’s surgeries:
FDA warns healthcare providers and patients that thermography is not an adequate substitution for mammography in detecting or diagnosing breast cancer:
FDA cautions that certain implantable pulse generators (IPGs) have a software error that
interferes with pacing:
FDA warns that Swan-Ganz Thermodilution Catheters may be incorrectly assembled, resulting
in increased risk of blood vessel perforation, inaccurate readings, or unintended treatments:
Safety alert due to detached plastic fragments found in transseptal needles:
Safety alert due to detached plastic fragments found in transseptal needles:
FDA warns that certain LIFEPAK defibrillators may “lockup” after delivering a shock, resulting
in required restart before use:
FDA issues safety alert regarding CoaguCheck test strips due to strips providing incorrect
results:
FDA warns that Vial2Bag fluid transfer systems may not adequately transfer medication, leading to over- or under-dosing patients:
FDA identifies Draegar VentStar and ID Breathing Circuits and Anesthesia Sets as being
incorrectly assembled, resulting in improper oxygen support:
FDA warns neurosurgeons of software problem with Synergy Cranial Software and the
StealthStations S7 Cranial Software, resulting in improper information being displayed:
FDA warns healthcare providers of increased mortality rates when using certain paclitaxel-
coated balloons and stents:
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