Archives

The FDA has identified a Class I recall of the Seattle-Positive Airway Pressure (PAP) Plus system and breathing circuit and/or anesthesia kits by Draeger Medical due to a manufacturing error. Used in a hospital setting, the Draeger Medical Seattle PAP Plus system conveys “Bubble continuous […]

Novis PR LLC, of San Juan, Puerto Rico, has announced a voluntarily recall of one lot (Lot D20911, expiration date 10/25) of its G-Suppress DX Pediatric Drops at the consumer level because some cartons may contain an incorrect product that is not under a Novis […]

ICU Medical has recalled the replacement batteries for its Plum 360, Plum A+, and Plum A+3 Infusion Systems because of a manufacturing defect that diminishes battery life, according to the FDA. As of May 22, 2023, the recall has been identified as Class I, the […]

According to the FDA, the Perrigo Company has taken the proactive step of issuing a voluntary recall for specific batches of Gerber® Good Start® SootheProTM Powdered Infant Formula in the United States. Batches manufactured at the company’s Gateway Eau Claire, Wisconsin facility between January 02, […]

According to the FDA, BearCare, Inc.’s rechargeable Walnut Wearable Smart Thermometer (Walnut Thermometer) has been voluntarily recalled following user reports of injuries that include skin burns. An over-the-counter device that can be recharged, the Walnut Thermometer is indicated to continuously monitor the chest temperature of […]

On May 10, 2023, the FDA issued an update on approved uses of Apyx Medical’s Renuvion/J-Plasma device system for select aesthetic skin procedures, including the clearance of a Renuvion/J-Plasma hand piece. A medical device comprised of a handpiece and a plasma generator, the Renuvion/J-Plasma system […]

According to the FDA, Seoul, South Korea-based SD Biosensor, Inc. is requesting that U.S. consumers discontinue use and dispose of select Pilot COVID-19 At-Home Tests because one of the product’s components was found to be contaminated with possibly harmful bacteria. An over-the-counter rapid antigen test, […]

The FDA is calling to attention the risk of exposure to harmful levels of radiation during use of the Safe-T-Lite UV Wand manufactured by Max-Lux Corporation Limited. Officials say that even after a few seconds of use, the device could expose its user and/or a […]

According to the FDA, certain two-, five- and 10-pound bags of Gold Medal Unbleached and Bleached All Purpose Flour with “better if used by” dates of March 27, 2024, and March 28, 2024, have been voluntary recalled by General Mills due to a potential Salmonella […]

The FDA is calling to attention a Class I recall of the BALLARD ACCESS Closed Suction System for Neonates/Pediatrics with Y-Manifold/Elbow Manifold because cracked manifolds in the product may put patients at risk of inadequate ventilation and other major, possibly life-threatening injuries. Initiated by the […]

The FDA is calling to attention a Class I recall of certain reworked DreamStation CPAP and BiPAP machines because a number of the devices were assigned incorrect or duplicate serial numbers when they were first programmed, which could potentially result in inaccurate or insufficient therapy.  […]

According to the FDA, one lot of Atovaquone Oral Suspension, USP 750 mg/5mL has been voluntarily recalled by Camber Pharmaceuticals, Inc. at the consumer level because the product may be contaminated by Bacillus cereus.  The potential microbial contamination of the product poses the most risk […]