Manual Resuscitator Recall: Ambu Inc. Removes SPUR II Resuscitators Due to Blocked Manometer Port
A blocked manometer port on the Ambu SPUR II resuscitator may delay ventilation or cause barotrauma
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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.
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
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.
Applicator Recall: Integra LifeSciences Removes Extended Tip Applicator Due to Potential Sterility and Endotoxin Concerns
Extended Tip Applicator recall due to potential non-sterile product and high endotoxin levels. May cause inflammation or infection if used.
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.
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
Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices - Letter to Health Care Providers
The FDA is reminding the public about the safe use of hyperbaric oxygen therapy devices and is providing recommendations to help reduce potential risks.
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
Vascular Stent Recall: Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis Due to Risk of Resistance During Device Withdrawal
Boston Scientific Removes Carotid WALLSTENT Monorail Endoprosthesis due to risk of resistance during device withdrawal
B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter
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.
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