The U.S. Food and Drug Administration (FDA) issues safety alerts as needed to provide timely new safety information on human drugs, medical devices, vaccines, and other products, including biologics, dietary supplements, and cosmetics. The alerts are publicly available at the agency’s MedWatch website and contain “actionable information that may impact both treatment and diagnostic choices for healthcare professional and patient.”
This list will be updated when the FDA posts new reports.
Do Not Use RoyalVibe Health, CellQuicken, or Well-Being Reality Ultrasound Devices
On July 17, the FDA warned consumers not to use ultrasound devices manufactured and distributed by RoyalVibe Health, CellQuicken, or Well-Being Reality. According to the FDA, the devices have not been reviewed for safety and effectiveness and may result in adverse effects, including pain, burns, and nerve damage, among others. The FDA recommends that consumers not buy or use these devices and should instead seek professional medical care. In late December 2022, the FDA sent a warning letter to the CEO of the three companies regarding the devices.
Inhalation Aerosol Recalled
On July 6, 2023, Mumbai-based Cipla issued a voluntary recall of six batches of its Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) manufactured in November 2021. The drug was sold in the United States, and all batches expire in November of this year. There is a “reasonable probability” that the inhaler will not deliver the recommended dose due to a device defect. The company is notifying distributors and customers to arrange for the return and replacement of defective products. Consumers, distributors and retailers are being told to stop using and discard or return the product to the place of purchase.
Vascular Catheter System Recalled
On June 26, 2023, Teleflex and its Arrow International subsidiary recalled 262,016 Arrow Endurance Extended Dwell Peripheral Catheter systems after receiving 83 complaints that the device can separate or leak when in a patient’s blood vessel. This is a Class I recall, indicating the use of the devices may cause serious injury or death. The company reports 18 injuries and no deaths related to this recall. The company initiated the recall on May 19, 2023.
Packaging Mix-Up With Antipsychotic Drug
On June 14, 2023, Harvard Drug Group, under the label of Major Pharmaceuticals and Rugby Laboratories, initiated a voluntary recall of one lot of Ziprasidone Hydrochloride, used to treat bipolar disorder and other psychotic disorders, was found to contain blister packs labeled as and containing Dronabinol capsules, used to combat nausea associated with chemotherapy treatments.
Wearable Smartphone-Capable Thermometer Recalled
On June 8, 2023, a total of 979 BearCare Walnut Wearable Smart Thermometers were recalled. The devices are intended for home use to monitor the body temperature of infants and children up to 6 years of age. This is a Class I recall, indicating the use of the devices may cause serious injury or death due to the potential for overheating and leakage of corrosive chemicals from the device. The company received five complaints that the rechargeable device caused skin burns and irritation and initiated a recall on May 10, 2023.
Heart Pump Recalled
On May 18, 2023, Abiomed recalled 466 Impella 5.5 with SmartAssist System heart pump after receiving 179 customer complaints related to fluid leakage from the device. This is a Class I recall, indicating the use of the devices may cause serious injury or death. Abiomed reported three injuries and no deaths related to this recall. The company initiated a recall on April 17, 2023.
COVID-19 Home Tests Recalled
On May 25, 2023, SD Biosensor recalled 2.7 million Pilot COVID-19 At-Home Test kits that had been distributed in the United States by Roche Diagnostics after discovering that the liquid solution in the kits may have been contaminated. This is a Class I recall, indicating the use of the devices may cause serious injury or death. The FDA had earlier warned consumers not to use the kits. The company initiated a recall on March 23, 2023.
Infant Breathing Device Recalled
On May 24, 2023, the FDA recalled 570,459 positive airway pressure (PAP) Plus, VentStar and other breathing circuit/anesthesia kits manufactured by Draeger after the company found a manufacturing error that may cause glued connections to loosen before or during ventilation. This is a Class I recall, indicating the use of the devices may cause serious injury or death. Draeger reports that there have been no injuries or deaths related to this recall. The company initiated a recall on April 17, 2023.
Infusion Pumps Recalled
On May 22, 2023, the FDA recalled replacement batteries for ICU Medical infusion systems Plum 360, Plum A and Plum A+3. This is a Class I recall, indicating the use of the devices may cause serious injury or death. The replacement batteries have a manufacturing defect that substantially reduces the battery’s ability to power the pump. There are 1,904 of the devices included in the recall. The company initiated a recall on March 22, 2023.
Pediatric Drops Recalled
On May 19, 2023, Novis PR voluntarily recalled one lot of its G-Suppress DX Pediatric Drops because some of the cartons contained incorrect product. The incorrect product contains 60% ethyl alcohol and 5% benzocaine, both of which are serious dangers to infants and small children. The company said it had received no reports of adverse events or injuries related to this recall.
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