The Life2000 Ventilator provides breathing support. The system’s battery charging dongle may fail, preventing the system from charging.

MEGA SOFT and MEGA 2000 Patient Return Electrodes used during monopolar electrosurgery may cause serious patient burn injuries.

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.

Baxter International Inc. (NYSE:BAX) announced today it has issued an Urgent Medical Device Recall for Life2000 ventilators with an attached battery charger dongle. The recall is due to reports that the devices are not properly charging when there is damage to the battery charger dongle. Baxter ha

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.

Medtronic issued a recall for removal of NIM Contact EMG Reinforced Endotracheal Tubes and NIM (Standard) EMG Reinforced Endotracheal Tubes from inventory due to issues with tube blockage.

Inspire IV Implantable Pulse Generator Model 3028 recalled due to manufacturing defect, possibly requiring surgery to replace the device and restore therapy.

Philips North America LLC is updating instructions for SENSE XL Torso (1.5T and 3.0T) coils due to a potential overheating issue that may cause thermal injury.

The HeartMate LVAS System Monitor allows clinicians to monitor performance of an implanted LVAD device. Screen issues may cause accidental pump stop.

Philips Respironics is updating the instructions for OmniLab Advanced+ (OLA+) Ventilator due to failure in the alarm, resulting in therapy interruption or loss.

ZOLL Medical Corporation is updating instructions for 731 ventilators due to included MRI safety information, which may cause misuse and ventilator failure.

Philips Respironics is updating the use instructions for V30, A30, and A40 ventilators due to failure in the alarm, resulting in therapy interruption or loss.

American Health Packaging on behalf of BluePoint Laboratories is voluntarily recalling 21 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution.Risk Statement: The failed dissolution of pot

Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ is voluntarily recalling 114 batches of Potassium Chloride Extended-Release Capsules, USP (750 mg) 10 mEq K, to the consumer level. The product is being recalled because of failed dissolution. Risk Statement: The failed dissolution of potassium chlor

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

MEGA SOFT Pediatric Patient Return Electrodes used during monopolar electrosurgery may cause serious burn injuries to patients.

Vaporizer Sevoflurane Maquet Filling is part of the Flow anesthesia systems but may expose patients or health professionals to toxic hydrogen fluoride.

Arrow FiberOptix and UltraFlex IAB Catheter Kits provide circulatory support. A manufacturing issue may prevent the balloon from fully inflating.

Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot 1

Integrity Products , St Louis MO is voluntarily recalling tainted lot (HGW221116) within expiry of the Ram It & To The Moon capsules to the consumer level. FDA analysis founds these products to be tainted with sildenafil and Tadalafil. Sildenafil/Tadalafil is an FDA approved drug for the treatment o