FRANKLIN LAKES, N.J. (Sept. 12, 2025) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today expanded their Class I voluntary recall initiated in the United States on July 8, 2025 and expanded on July 17, 2025 to inform customers of worst-case performanc

t:slim X2 insulin pumps provide insulin to people with diabetes, but a speaker wiring issue may cause an error that makes the pump stop delivering insulin.

DreamStation devices may deliver incorrect therapy due to programming errors. Continued use could cause ineffective treatment or harm.

Dexcom is correcting G7 & ONE+ Apps that fail to alert users when sensors fail, potentially causing missed alerts and delayed treatment of hypo/hyperglycemia.

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program.

Listing of Medical Device 2024 Safety Communications

Read the FDA’s recommendations related to Accolade pacemaker devices by Boston Scientific and a potential need for early device replacement.

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.

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.

A blocked manometer port on the Ambu SPUR II resuscitator may delay ventilation or cause barotrauma

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.

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

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

Extended Tip Applicator recall due to potential non-sterile product and high endotoxin levels. May cause inflammation or infection if used.

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

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

The FDA is reminding the public about the safe use of hyperbaric oxygen therapy devices and is providing recommendations to help reduce potential risks.

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

Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis due to risk of resistance during device withdrawal

For Immediate Release - BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL,and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container.