Cook Medical Zenith Alpha 2 Thoracic Graft Recall Affects 695 Devices in 2025
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
2,756 recalls tagged with “immediate action”.
Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Listeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the green onions which were used only in Ahi Tuna Wasabi Poke.
No ingredient label. Product contains undeclared allergens (cashews, almonds, walnuts, Brazil nuts, pecans, pistachios)
No ingredient label. Product contains undeclared allergens (peanuts, almonds, cashew, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, almonds, wheat, and soy)
No ingredient label. Product contains undeclared allergens (peanuts, sesame, wheat, and soy)
Potential for the lid of the catheter connector to be in the incorrect position.
Potential for the lid of the catheter connector to be in the incorrect position.
The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values representing liver steatosis. This could potentially lead to inappropriate clinical decisions impacting overall care.
Potential for the lid of the catheter connector to be in the incorrect position.
Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for use. Expansion of RES 95214.
CGMP Deviations: Market complaints received for gritty texture (grainy)
Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. Affected probes will potentially display a lower temperature than the true value, which may lead to a delay in managing fever-related symptoms or infection.