June 1, 2020

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. 

March 24, 2020

The FDA is alerting patients and healthcare providers that certain EpiPen auto injectors may have a delayed response or may fail to inject. 

May 2, 2019

FDA warns healthcare providers about off-label use of Stryker Wingspan stent system. 

April 8, 2019

FDA warns consumers about unauthorized sale of previously owned test strips:

March 21, 2019
FDA identifies cyber security vulnerabilities in implantable cardiac devices:
March 6, 2019
FDA safety communication warns patients of software updated needed for LifeVest 4000 wearable defibrillators:
February 28, 2019

FDA safety communication urges caution when using robotically-assisted surgical devices in
certain women’s surgeries:

February 25, 2019

FDA warns healthcare providers and patients that thermography is not an adequate substitution for mammography in detecting or diagnosing breast cancer:

February 22, 2019
FDA warns that ChemoLock vial spikes may contain plastic particles that can enter the bloodstream:
February 15, 2019

FDA cautions that certain implantable pulse generators (IPGs) have a software error that
interferes with pacing:

February 5, 2019

FDA warns that Swan-Ganz Thermodilution Catheters may be incorrectly assembled, resulting
in increased risk of blood vessel perforation, inaccurate readings, or unintended treatments:

February 4, 2019

Safety alert due to detached plastic fragments found in transseptal needles:

February 1, 2019

Safety alert due to detached plastic fragments found in transseptal needles:

February 1, 2019

FDA warns that certain LIFEPAK defibrillators may “lockup” after delivering a shock, resulting
in required restart before use:

February 1, 2019

FDA issues safety alert regarding CoaguCheck test strips due to strips providing incorrect
results:

February 1, 2019

FDA warns that Vial2Bag fluid transfer systems may not adequately transfer medication, leading to over- or under-dosing patients:

January 25, 2019

FDA identifies Draegar VentStar and ID Breathing Circuits and Anesthesia Sets as being
incorrectly assembled, resulting in improper oxygen support:

January 18, 2019

FDA warns neurosurgeons of software problem with Synergy Cranial Software and the
StealthStations S7 Cranial Software, resulting in improper information being displayed:

January 17, 2019

FDA warns healthcare providers of increased mortality rates when using certain paclitaxel-
coated balloons and stents:

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