East Windsor, New Jersey. Aurobindo Pharma USA, Inc., on behalf of AuroHealth, is voluntarily recalling one lot (refer table below) of Healthy Living Migraine Relief, Acetaminophen 250mg, Aspirin (NSAID) 250mg & Caffeine 65mg tablets, to the consumer level as sold through Amazon to known within th
The Life2000 Ventilator provides breathing support. The system’s battery charging dongle may fail, preventing the system from charging.
London, July 22, 2024 – Hikma Pharmaceuticals PLC (Hikma, Group), today announces that its subsidiary Hikma Pharmaceuticals USA, Inc. is extending its voluntary recall of one lot (listed below) of Acetaminophen Injection, 1000mg/100mL, (10mg/mL) to the consumer/user level. The product is being recal
Main Products, Inc. is voluntarily recalling all lots of “Umary Acido Hialuronico, Suplemento Alimenticio – 30 Capletas de 850mg” to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products containing
UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication
Listing of Medical Device 2024 Safety Communications
The FDA posts letters to health care providers about the safe use of medical devices.
Medtronic initiates recall for silicone-based EMG endotracheal tubes due to the risk of airway obstruction and ventilation failure.
Endo, Inc (OTCQX: NDOI) (“Endo”), announced today that one of its operating subsidiaries, Endo USA, Inc., is voluntarily recalling one lot of Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.25 mg tablets, which may also appear as Clonazepam Orally Disintegrating Tablets, USP (C-IV) 0.125 tabl
The FDA has received reports of airway obstruction and ventilation failure for certain EMG endotracheal tubes.
The NIM CONTACT and Standard Reinforced EMG Endotracheal Tubes may obstruct the patient’s airway.
Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for certain lots of the Volara system single-patient use circuit and blue ventilator adapter assembly (see Figure 1). The recall is due to reports of the handset plug disconnecting from the nebulizer p
Philips Respironics is updating the instructions for OmniLab Advanced+ (OLA+) Ventilator due to failure in the alarm, resulting in therapy interruption or loss.
Lilburn, GA, GURU INC. is voluntarily recalling Infla-650 Herbal Dietary Supplement Capsules, Lot No. IN-032, 700 mg to the consumer/user level. Infla-650 capsules has been found to be tainted with acetaminophen, diclofenac and phenylbutazone, which are not listed on the label. Products containing a
Certain Bausch + Lomb I-Pack Injection Kits that are used to inject medicine into the eye may not be completely sterile.
2024 Medical Device Recalls
Chula Vista, CA, SoloVital.com is voluntarily recalling all lots of Umary Acido Hialuronica, Suplemento Alimenticio – 30 Capletas de 850mg to the consumer level. FDA laboratory analysis confirmed that UMARY has been found to be tainted with the drug ingredients, diclofenac and omeprazole. Products c
The HAMILTON-C6 Medical Ventilator provides breathing support in health settings. A software issue may cause the HAMILTON-C6 ventilator to fail to restart ventilation.
MEGA SOFT and MEGA 2000 Patient Return Electrodes used during monopolar electrosurgery may cause serious patient burn injuries.
The FDA issued a LHCP to notify providers that blood culture media bottles (product code MDB) are being added to the medical device shortage list.