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

Medline Industries, LP is recalling the Sub-G Endotracheal Tube with Subglottic Suction due to detachment or tearing of the inflation tube and other components from the main tube.

Omnipod DASH Insulin Management System’s Personal Diabetes Manager may have battery issues including swelling, fluid leakage, and extreme overheating.

Do not use high-level disinfection methods for reprocessing affected urological endoscopes from Karl Storz.

HomeoCare Laboratories Inc., a manufacturer of homeopathic products, is voluntarily recalling two batches of Homeopathic StellaLife Oral Care Products listed in the table below manufactured in 2024 due to FDA findings of microbial contamination. This recall is to be performed at the consumer level.

The software error may cause numbers or letters to be missing from the displayed text and may result in the mechanical depth stop being set too short or too long.

On February 20, 2024, Medline Industries, LP initiated a nationwide recall of 6 SubG Endotracheal Tubes with Subglottic Suction and 10 kits that contain these devices. The inflation tube and other device components have become detached and/or torn from the main tube, resulting in moisture buildup, l

Nimbus II infusion pumps may experience one or more issues that can cause severe patient injury and death.

Sagent Pharmaceuticals today announced the voluntary nationwide recall of two lots of Docetaxel Injection, USP (80 mg per 8 mL multi-dose vials and 160 mg per 16 mL multi-dose vials). The product was distributed by Sagent Pharmaceuticals. Sagent has initiated this voluntary recall of Docetaxel Injec