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Mobile Power Unit AC Power Cord Recall: Abbott Medical Removes AC Power Cord Associated with HeartMate Mobile Power Unit (MPU) Due to Potential Risk of the Cord Not Locking into Place

Abbott Medical is removing power cords associated with the HeartMate Mobile Power Unit due to a potential risk of the cord not locking into place.

http://www.fda.gov/medical-devices/medical-device-recalls/mobile-power-unit-ac-power-cord-recall-abbott-medical-removes-ac-power-cord-associated-heartmate

 
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Breathing Circuit Set Recall: Hamilton Medical, Inc. Removes Coaxial Breathing Circuit Set Due to Possible Inner Blue Tube Cracks That May Impact Ventilation

Hamilton Medical is recalling certain coaxial breathing sets due to a defect that may cause cracks in the inner tube, risking patient rebreathing exhaled gases.

http://www.fda.gov/medical-devices/medical-device-recalls/breathing-circuit-set-recall-hamilton-medical-inc-removes-coaxial-breathing-circuit-set-due-possible

 
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Green Lumber Holding, LLC Issues Consumer Alert on Counterfeit Products Following FDA Findings

Costa Mesa, California August 28, 2025 – Green Lumber Holding, LLC (“Green Lumber”) is alerting consumers that counterfeit products misrepresented as genuine Green Lumber have been identified and may pose health risks.

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/green-lumber-holding-llc-issues-consumer-alert-counterfeit-products-following-fda-findings

 
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Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive

ICU Medical is correcting the Plum Duo infusion system due to pump software issues that may cause the device to become unresponsive.

http://www.fda.gov/medical-devices/medical-device-recalls/infusion-pump-correction-icu-medical-inc-issues-correction-plum-duo-infusion-system-due-software

 
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Ventilator Correction: Hamilton Medical AG Corrects HAMILTON-C6 Due to Risk of Ventilation Interruption from Defective Circuit Board

Hamilton is repairing certain HAMILTON-C6 ventilators to replace a defective circuit board that can interrupt ventilation, risking serious injury or death.

http://www.fda.gov/medical-devices/medical-device-recalls/ventilator-correction-hamilton-medical-ag-corrects-hamilton-c6-due-risk-ventilation-interruption

 
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DermaRite Industries Expands Voluntary Nationwide Recall Due to Potential Burkholderia cepacia Contamination

DermaRite Industries, LLC is expanding the voluntary recall initiated on July 16, due to potential microbial contamination identified as Burkholderia cepacia complex. Out of an abundance of caution the voluntary recall has expanded to include additional products and lots, which can be found in the t

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dermarite-industries-expands-voluntary-nationwide-recall-due-potential-burkholderia-cepacia

 
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Unichem Pharmaceuticals (USA) Inc. Issues Voluntary Nationwide Recall of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, Due to Mislabeling

08/27/2025– East Brunswick, NJ, Unichem Pharmaceuticals (USA), Inc. is voluntarily recalling one (1) lot of Cyclobenzaprine Hydrochloride Tablets USP 10 mg, to the consumer level. The Cyclobenzaprine 10mg (90ct) label was inadvertently placed on a bottle containing Meloxicam

http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/unichem-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-cyclobenzaprine-hydrochloride

 
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FDA Update on the Safety of Ixchiq (Chikungunya Vaccine, Live). FDA Suspends Biologics License: FDA Safety Communication

On August 22, 2025,the US FDA’s Center for Biologics Evaluation and Research has suspended the biologics license for Valneva Austria GmbH’s Ixchiq (Chikungunya Vaccine, Live). This vaccine was initially approved by FDA under the accelerated approval pathway in November of 2023 for the prevention of

http://www.fda.gov/safety/medical-product-safety-information/fda-update-safety-ixchiq-chikungunya-vaccine-live-fda-suspends-biologics-license-fda-safety