Archives

After receiving numerous customer reports of adverse health events, Medtronic plc of Ireland is issuing an urgent notification with updated instructions for its MiniMed™ 600 and 700 series insulin pumps. Due to the potential risk to consumers, the FDA is referring to Medtronic’s notification as […]

According to the FDA, Rosemead, California-based 123herbals has recalled all lots of its Vail-Bon Jie Yang Wan capsules out of concern that the products contain undeclared dexamethasone and chlorpheniramine. Announced by the company on September 18, 2024, the company said it initiated the voluntary, nationwide […]

Garden Grove, California-based LQNN, Inc., has recalled its Banh Ba Xa and several varieties of its Banh Pia, under multiple lot numbers and best-by dates, due to the potential presence of egg, an ingredient not declared on the product label. Individuals who live with an […]

The FDA is calling to attention a Class I recall of Megadyne’s MEGA 2000 and MEGA Soft Reusable Patient Return Electrodes, which have been found to be capable of causing serious burn injuries. Indicated for use by both pediatric and adult patients, MEGA 2000 and […]

Cipla US, a wholly-owned subsidiary of Cipla Limited, of Mumbai, India and New Jersey, USA, has voluntarily recalled six batches of its Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) because of a defect in the product’s container. The consumer-level US recall, initiated by […]

On June 26, 2023, the FDA alerted consumers of its expanded advisory against the use of certain brands of ultraviolet (UV) wands used for disinfection. The products under examination are believed to expose the user and any nearby person to levels of ultraviolet-C (UV-C) radiation […]

Teleflex and Arrow International have recalled ARROW Endurance Extended Dwell Peripheral Catheter System because the catheter was found prone to separating or leaking, according to the FDA. Due to the significant health risks (“serious injuries or death”) posed by the potential issue, the recall has […]

The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories, based in La Vergne, Tennessee, is voluntarily recalling a single lot of Dronabinol Capsules, USP, 2.5 mg and Ziprasidone Hydrochloride Capsules, 20 mg because of a label mix-up, according to the FDA. Company officials […]

On June 8, 2023, Wawona Frozen Foods, Inc. announced a voluntary recall of its Organic DayBreak Blend, processed and sold in 2022, because the product’s Mexico-grown organic frozen strawberries may have been contaminated with Hepatitis A, according to the FDA. Distributed to Costco Wholesale stores […]

On June 12, 2023, the FDA announced that the May 12, 2023 recall of BearCare, Inc.’s Rechargeable Walnut Wearable Smart Thermometer has been labeled Class I, due to risk of serious injuries or death. A re-usable thermometer used with a mobile phone application, the rechargeable […]

The FDA is calling to attention an Urgent Medical Device Removal notice sent by Getinge/Maquet to healthcare providers and facilities on May 18, 2023, which warned users against using all Quadrox Oxygenators and select Getinge/Maquet Venous Hardshell Cardiotomy Reservoirs. According to officials, the device’s “potentially […]

According the FDA, a recall of certain Impella 5.5 with SmartAssist sets that was initiated by Abiomed on April 17, 2023, has since been labeled Class I, the most serious type, due to a risk of major injuries or death. Indicated to support the pumping […]